|
Device |
plate, fixation, bone |
Product Code | HRS |
Regulation Number |
888.3030
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
4-WEB, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
4WEB MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
4WEB, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
A PLUS BIOTECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AAP IMPLANTATE AG |
|
SUBSTANTIALLY EQUIVALENT
|
22
|
ACUMED LLC |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
ACUMED, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ACUTE INNOVATIONS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ADAPTIVE SPECIALTY, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADDITIVE ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADDITIVE ORTHOPAEDICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ADDITIVE ORTHOPAEDICS, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADVANCED ORTHOPAEDIC SOLUTIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AESCULAP IMPLANT SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARTHREX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
12
|
ARTHREX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
12
|
ARTHROSURFACE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ASCENSION ORTHOPEDIC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASCENSION ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
AUXEIN MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AUXEIN MEDICAL PRIVATE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
AVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AVANTI ORTHOPAEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BEIJING KEYI MEDICAL DEVICE TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BEIJING LIBEIER BIO-ENGINEERING INSTITUTE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMEDICAL ENTERPRISES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMEDICAL ENTERPRISES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMET |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMET INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMET INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOMET MANUFACTURING |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMET MANUFACTURING CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
BIOMET MICOFIXATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOMET MICROFIXATION |
|
SUBSTANTIALLY EQUIVALENT
|
11
|
BIOMET MICROFIXATION, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOMET TRAUMA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMET TRAUMA (AKA EBI, LP) |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BIOMET, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
BIOPRO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BODYCAD LABORATORIES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BODYCAD LABORATORIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BONEBRIDGE AG |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
CANWELL MEDICAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARBOFIX ORTHOPEDICS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
CARBOFIX ORTHOPEDICS, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHANGZHOU DEAN MEDICAL INSTRUMENT CO, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHANGZHOU DINGJIAN MEDICAL APPLIANCE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CITIEFFE S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONVENTUS ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CONVENTUS ORTHOPAEDICS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONVENTUS ORTHOPAEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CROSSROADS EXTEMITY SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CROSSROADS EXTREMITY SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CROSSROADS EXTREMITY SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
DEPUY ORTHOPAEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
DEPUY SYNTHES |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
DEROYAL INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DOUBLE MEDICAL TECHNOLOGY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EBI, L.P. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EBI,LLC D/B/A BIOMET TRAUMA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EMERGE MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
EMINENT SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENDEAVOR ORTHOPAEDICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENHATCH ORTHOPAEDICS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EPIC EXTREMITY, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
EXACTECH, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXACTECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXREMITY MEDICAL, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXSOMED CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXTREMITY MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
EXTREMITY MEDICAL, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
FIELD ORTHOPAEDICS PTY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FIXIER, S.A. DE C.V. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FLOWER ORTHOPEDICS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
FORMA MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUSION INNOVATIONS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUSION ORTHOPEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUSION ORTHOPEDICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FX SOLUTIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GENESIS FRACTURE CARE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
GLOBUS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
GLW MEDICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GM DOS REIS INDUSTRIA E COMERCIO LTDA |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
GM DOS REIS INDUSTRIA E COMERICO LTDA. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GPC MEDICAL LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GPC MEDICAL LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GRAHAM MEDICAL TECHNOLOGIES, L.L.C. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GRAHAM MEDICAL TECHNOLOGIES, L.L.C. DBA GRAMEDICA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GRAMERCY EXTREMITY ORTHOPEDICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
GREENS SURGICALS PVT. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANKIL TECH MEDICAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOSPITAL EQUIPMENT MANUFACTURING COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
HOWMEDICA OSTEONICS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
I.T.S. GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IBALANCE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
IMPACT MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IN2BONES SAS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
IN2BONES USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IN2BONES USA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
13
|
IN2BONESUSA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
INDUSTRIAS MEDICAS SAMPEDRO S.A.S |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTAI TECHNOLOGY CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTEGRA LIFESCIENCES CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
INTERNAL FIXATION SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTRAUMA S.P.A |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JACE MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JACE MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JEIL MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
23
|
JIANGSU BAIDE MEDICAL INTRUMENT CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LT |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU TRAUHUI MEDICAL INSTRUMENT CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JM LONGYEAR MANUFACTURING, LLC D.B.A. ABLE MEDICAL DEVICES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JM LONGYEAR MANUFACTURING, LLC D/B/A ABLE MEDICAL DEVICES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KENS FINEMEDTECH SDN. BHD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KLS MARTIN L.P. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
KLS MARTIN LP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KLS-MARTIN L.P. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
KOROS USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LAURA CATTABRIGA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LEITH MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIFE SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LIFE SPINE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MAHE MEDICAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAXXION MEDICAL, LLC / BAUMER SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MBD MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MCGINLEY ORTHPAEDIC INNOVATIONS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDARTIS AG |
|
SUBSTANTIALLY EQUIVALENT
|
28
|
MEDLINE INDUSTIRES, LP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDLINE INDUSTRIES, LP |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDLINE, INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEMOMETAL TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MERETE MEDICAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MERIL HEALTHCARE PVT. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIAMI DEVICE SOLUTIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIAMI DEVICE SOLUTIONS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
MICROWARE PRECISION CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MIRUS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MX ORTHOPEDICS, CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
N.M.B. MEDICAL APPLICATIONS, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NARANG MEDICAL LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NARANG MEDICAL USA CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEBULA SURGICAL PRIVATE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEOORTHO PRODUCTOS ORTHOPEDICOS S/A |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEOORTHO PRODUTOS ORTOPEDICOS S/A |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEOSTEO |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NETBIOLOGICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEWCLIP TECHNICS |
|
SUBSTANTIALLY EQUIVALENT
|
18
|
NEWDEAL SAS |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
NEXTREMITY SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
NORMED MEDIZIN-TECHNIK GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
NOVASTEP |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
NVISION BIOMEDICAL TECHNOLOGIES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORTHO LIFE SYSTEMS PRIVATE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHO SELECT IMPLANT TECHNOLOGY GESELLSCHAFT |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHO SOLUTIONS LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ORTHO SOLUTIONS UK LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORTHO-PRO LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOCARE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOFIX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOFIX SRL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ORTHOFIX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOHELIX SURGICAL DESIGNS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
13
|
ORTHOPAEDIC IMPLANT COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ORTHOPEDIATRICS, CORP |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ORTHOPEDIATRICS, CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
ORTHOPEDIATRICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOPRO LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSTEOMED |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
OSTEOMED L.P. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
OSTEOMED LP |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
OSTEONIC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PANTHEON MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARAGON 28 |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PARAGON 28, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
PEGA MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PIONEER SURGICAL TECHNOLOGY, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PIONEER SURGICAL TECHNOLOGY, INC D.B.A RESOLVE SURGICAL TECH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PIONEER SURGICAL TECHNOLOGY, INC., DBA RTI SURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RIVERPOINT MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
S H PITKAR ORTHOTOOLS PVT LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCIENCE FOR BIOMATERIALS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SCIENCES ET BIO MATERIAUX (SBM) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI MICROPORT ORTHOPEDICS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHOULDER OPTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SIG MEDICAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIG MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SKELETAL DYNAMICS INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SKELETAL DYNAMICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SKELETAL DYNAMICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
SKY SURGICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SMITH & NEPHEW, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
25
|
SMV SCIENTIFIC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOLANA SURGICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SONOMA ORTHOPEDIC PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STABILIZ ORTHOPAEDICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
STRYKER |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
STRYKER CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
STRYKER GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
20
|
STRYKER LEIBINGER GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER LEIBINGER GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER TRAUMA AG |
|
SUBSTANTIALLY EQUIVALENT
|
16
|
STUCKENBROCK MEDIZINTECHNIK GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUSPENSION ORTHOPAEDIC SOLUTIONS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNTEC SCIENTIFIC CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SYNTHES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNTHES (USA) |
|
SUBSTANTIALLY EQUIVALENT
|
15
|
SYNTHES (USA) LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SYNTHES (USA) PRODUCTS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
SYNTHES (USA) PRODUCTS LLC/DEPUY ORTHOPAEDICS INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SYNTHES (USA) PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SYNTHES GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SYNTHES INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNTHES USA |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
TDM CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
TDM CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TECHFIT DIGITAL SURGERY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THE ORTHOPAEDIC IMPLANT COMPANY (OIC) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TIANJIN WALKMAN BIOMATERIAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOBY ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TORNIER INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TORNIER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TREACE MEDICAL CONCEPTS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TREACE MEDICAL CONCEPTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
TRIDENT ORTHOPEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRILLIANT SURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TRILLIANT SURGICAL LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
TRILLIANT SURGICAL, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TRIMED, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRIMED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
TRUEMED GROUP LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TRUEMED GROUP, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TYBER MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TYBER MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TYBER MEDICAL, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
VILEX LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
VILEX, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WEIGAO ORTHOPAEDIC DEVICE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WISHBONE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
WRIGHT MEDICAL TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
32
|
XIAMEN DOUBLE ENGINE MEDICAL MATERIAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
XIAMEN DOUBLE ENGLINE MEDICAL MATERIAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ZIMMER INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER SWITZERLAND MANUFACTURING GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
13
|
ZIMMER,INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
ACUTE Innovations, LLC |
II |
Jan-28-2014 |
2 |
Acumed LLC |
II |
Feb-29-2024 |
3 |
Acumed LLC |
II |
Feb-14-2017 |
4 |
Acumed LLC |
II |
Apr-25-2014 |
5 |
Acumed LLC |
II |
Jun-16-2010 |
6 |
Acute Innovations Llc |
II |
Dec-01-2011 |
7 |
Arthrex, Inc. |
II |
Apr-09-2021 |
8 |
Arthrex, Inc. |
II |
Jul-29-2020 |
9 |
Arthrex, Inc. |
II |
Apr-08-2016 |
10 |
Biomet |
II |
Jun-09-2020 |
11 |
Biomet Microfixation, Inc. |
II |
Jan-24-2012 |
12 |
Biomet Microfixation, Inc. |
II |
May-27-2009 |
13 |
Biomet, Inc. |
II |
Jan-21-2021 |
14 |
Biomet, Inc. |
II |
May-26-2016 |
15 |
Biomet, Inc. |
II |
Dec-18-2015 |
16 |
Biomet, Inc. |
II |
Jul-10-2015 |
17 |
Biomet, Inc. |
II |
Jul-08-2015 |
18 |
Biomet, Inc. |
II |
Aug-13-2014 |
19 |
Biomet, Inc. |
II |
Jan-10-2014 |
20 |
Biomet, Inc. |
II |
Apr-19-2012 |
21 |
Depuy Orthopaedics, Inc. |
II |
Mar-07-2011 |
22 |
Depuy Orthopaedics, Inc. |
II |
Feb-11-2009 |
23 |
Epic Extremity, LLC |
II |
May-15-2018 |
24 |
Flower Orthopedics Corporation |
II |
Oct-06-2021 |
25 |
Flower Orthopedics Corporation |
II |
Aug-12-2020 |
26 |
GRAMERCY EXTREMITY ORTHOPEDICS |
II |
Apr-17-2023 |
27 |
I.T.S. GmbH |
II |
Jun-04-2019 |
28 |
In2Bones, SAS |
II |
Aug-03-2017 |
29 |
In2Bones, SAS |
II |
Jan-06-2017 |
30 |
Integra LifeSciences Corp. |
II |
Jun-14-2016 |
31 |
Integra LifeSciences Corp. |
II |
Aug-01-2012 |
32 |
Integra LifeSciences Corp. |
II |
Mar-02-2012 |
33 |
Integra LifeSciences Corp. |
II |
Jan-25-2011 |
34 |
K2M, Inc |
II |
Apr-12-2021 |
35 |
Miami Device Solutions, LLC. |
II |
Dec-05-2019 |
36 |
NewDeal SA |
II |
Jul-16-2018 |
37 |
Nextremity Solutions |
II |
Feb-11-2020 |
38 |
Nextremity Solutions |
II |
Nov-22-2019 |
39 |
OrthoPediatrics Corp |
II |
Sep-18-2015 |
40 |
OrthoPediatrics Corp |
II |
Nov-14-2013 |
41 |
OrthoPediatrics Corp |
II |
Nov-22-2012 |
42 |
OrthoPediatrics Corp |
II |
Jul-20-2012 |
43 |
Orthofix, Inc |
II |
Jun-07-2018 |
44 |
Orthohelix Surgical Designs Inc |
II |
Jan-11-2012 |
45 |
Orthohelix Surgical Designs Inc |
II |
Aug-29-2011 |
46 |
Paragon 28, Inc. |
II |
Jul-25-2022 |
47 |
Smith & Nephew Inc |
II |
Aug-31-2010 |
48 |
Smith & Nephew, Inc. |
II |
Feb-01-2022 |
49 |
Smith & Nephew, Inc. |
II |
Dec-10-2021 |
50 |
Smith & Nephew, Inc. |
II |
Nov-18-2021 |
51 |
Smith & Nephew, Inc. |
II |
Sep-09-2020 |
52 |
Smith & Nephew, Inc. |
II |
Jan-24-2018 |
53 |
Smith & Nephew, Inc. |
II |
Jan-19-2018 |
54 |
Smith & Nephew, Inc. |
II |
Apr-18-2017 |
55 |
Smith & Nephew, Inc. |
II |
Apr-14-2017 |
56 |
Smith & Nephew, Inc. |
II |
Dec-04-2015 |
57 |
Stryker GmbH |
II |
Jan-07-2020 |
58 |
Stryker Howmedica Osteonics Corp. |
II |
Feb-16-2011 |
59 |
Stryker Howmedica Osteonics Corp. |
II |
Apr-13-2009 |
60 |
Synthes (USA) Products LLC |
II |
Mar-01-2024 |
61 |
Synthes (USA) Products LLC |
II |
Aug-17-2020 |
62 |
Synthes (USA) Products LLC |
II |
Aug-11-2016 |
63 |
Synthes (USA) Products LLC |
II |
Jun-10-2016 |
64 |
Synthes (USA) Products LLC |
II |
Nov-06-2015 |
65 |
Synthes (USA) Products LLC |
II |
Oct-30-2015 |
66 |
Synthes (USA) Products LLC |
II |
Oct-15-2015 |
67 |
Synthes (USA) Products LLC |
II |
Nov-27-2013 |
68 |
Synthes (USA) Products LLC |
II |
Aug-26-2013 |
69 |
Synthes Spine |
II |
Jun-01-2009 |
70 |
Synthes Spine |
II |
May-21-2009 |
71 |
Synthes USA (HQ), Inc. |
II |
Nov-02-2010 |
72 |
Synthes USA (HQ), Inc. |
II |
Feb-24-2010 |
73 |
Synthes USA HQ, Inc. |
II |
Nov-22-2013 |
74 |
Synthes USA HQ, Inc. |
II |
Aug-26-2013 |
75 |
Synthes USA HQ, Inc. |
II |
Jun-19-2013 |
76 |
Synthes USA HQ, Inc. |
II |
Mar-15-2013 |
77 |
Synthes, Inc. |
II |
Jan-29-2020 |
78 |
Synthes, Inc. |
II |
Mar-25-2014 |
79 |
Synthes, Inc. |
II |
Mar-11-2014 |
80 |
Toby Orthopaedics, Inc. |
II |
Dec-04-2019 |
81 |
Treace Medical Concepts, Inc. |
II |
Aug-23-2024 |
82 |
TriMed Inc. |
II |
Jan-31-2024 |
83 |
TriMed Inc. |
II |
Nov-13-2019 |
84 |
TriMed Inc. |
II |
Oct-10-2019 |
85 |
TriMed Inc. |
II |
Apr-23-2019 |
86 |
TriMed Inc. |
II |
Aug-18-2018 |
87 |
Trilliant Surgical Ltd. |
II |
Sep-04-2015 |
88 |
Trilliant Surgical Ltd. |
II |
Aug-31-2015 |
89 |
Trimed Inc |
II |
Sep-20-2016 |
90 |
Wishbone Medical, Inc. |
II |
Jun-04-2021 |
91 |
Wright Medical Technology Inc |
II |
Dec-17-2021 |
92 |
Wright Medical Technology Inc |
II |
Aug-09-2010 |
93 |
Wright Medical Technology, Inc. |
II |
Apr-26-2023 |
94 |
Wright Medical Technology, Inc. |
II |
Feb-24-2023 |
95 |
Wright Medical Technology, Inc. |
II |
Mar-15-2022 |
96 |
Wright Medical Technology, Inc. |
II |
Feb-25-2022 |
97 |
Wright Medical Technology, Inc. |
II |
Dec-20-2021 |
98 |
Wright Medical Technology, Inc. |
II |
Nov-25-2019 |
99 |
Wright Medical Technology, Inc. |
II |
Sep-01-2015 |
100 |
Wright Medical Technology, Inc. |
II |
Apr-22-2015 |
|
|
|
|