|
Device |
plate, fixation, bone |
Product Code | HRS |
Regulation Number |
888.3030
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
4WEB MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
4WEB, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
A PLUS BIOTECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AAP IMPLANTATE AG |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
ACUMED LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ADDITIVE ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADDITIVE ORTHOPAEDICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADVANCED ORTHOPAEDIC SOLUTIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARTHREX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
12
|
ARTHREX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AUXEIN MEDICAL PRIVATE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
AUXEIN MEDICAL PVT. LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AVANTI ORTHOPAEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOMET INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOMET MICOFIXATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOMET MICROFIXATION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
BODYCAD LABORATORIES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BODYCAD LABORATORIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BONEBRIDGE AG |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
CARBOFIX ORTHOPEDICS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARBOFIX ORTHOPEDICS, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CITIEFFE S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CROSSROADS EXTEMITY SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CROSSROADS EXTREMITY SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CROSSROADS EXTREMITY SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
DEPUY SYNTHES |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
DOUBLE MEDICAL TECHNOLOGY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ENDEAVOR ORTHOPAEDICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EPIC EXTREMITY, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXACTECH, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXREMITY MEDICAL, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXSOMED CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXTREMITY MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EXTREMITY MEDICAL, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FIELD ORTHOPAEDICS PTY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FIXIER, S.A. DE C.V. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FORMA MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUSION INNOVATIONS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUSION ORTHOPEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUSION ORTHOPEDICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GLOBUS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
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
|
GRAMERCY EXTREMITY ORTHOPEDICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
HANKIL TECH MEDICAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOSPITAL EQUIPMENT MANUFACTURING COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
I.T.S. GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IN2BONES USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IN2BONES USA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
12
|
INDUSTRIAS MEDICAS SAMPEDRO S.A.S |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTAI TECHNOLOGY CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTEGRA LIFESCIENCES CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTRAUMA S.P.A |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JACE MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JEIL MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
11
|
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
|
KLS MARTIN L.P. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KLS-MARTIN L.P. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
LEITH MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAXXION MEDICAL, LLC / BAUMER SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MCGINLEY ORTHPAEDIC INNOVATIONS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDARTIS AG |
|
SUBSTANTIALLY EQUIVALENT
|
14
|
MEDLINE INDUSTIRES, LP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDLINE INDUSTRIES, LP |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MERIL HEALTHCARE PVT. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIAMI DEVICE SOLUTIONS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROWARE PRECISION CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MIRUS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NEBULA SURGICAL PRIVATE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEOSTEO |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NETBIOLOGICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEWCLIP TECHNICS |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
NEXTREMITY SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
NOVASTEP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NVISION BIOMEDICAL TECHNOLOGIES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORTHO LIFE SYSTEMS PRIVATE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHO SOLUTIONS UK LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORTHOFIX SRL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ORTHONOVIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOPAEDIC IMPLANT COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ORTHOPEDIATRICS, CORP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSTEOMED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSTEONIC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARAGON 28, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
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
|
SIG MEDICAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIG MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SKELETAL DYNAMICS INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SKELETAL DYNAMICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SKELETAL DYNAMICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SKY SURGICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SMITH & NEPHEW, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
STRYKER |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
13
|
STUCKENBROCK MEDIZINTECHNIK GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNTHES (USA) LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNTHES (USA) PRODUCTS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SYNTHES (USA) PRODUCTS LLC/DEPUY ORTHOPAEDICS INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNTHES (USA) PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SYNTHES GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TDM CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
TDM CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TECHFIT DIGITAL SURGERY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THE ORTHOPAEDIC IMPLANT COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TORNIER INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TREACE MEDICAL CONCEPTS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TREACE MEDICAL CONCEPTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
TRIDENT ORTHOPEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRILLIANT SURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TRIMED, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRIMED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
TRUEMED GROUP LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
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
|
WISHBONE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
WRIGHT MEDICAL TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ZIMMER GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ZIMMER SWITZERLAND MANUFACTURING GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Acumed LLC |
II |
Feb-29-2024 |
2 |
Arthrex, Inc. |
II |
Apr-09-2021 |
3 |
Arthrex, Inc. |
II |
Jul-29-2020 |
4 |
Biomet |
II |
Jun-09-2020 |
5 |
Biomet, Inc. |
II |
Jan-21-2021 |
6 |
Epic Extremity, LLC |
II |
May-15-2018 |
7 |
Flower Orthopedics Corporation |
II |
Oct-06-2021 |
8 |
Flower Orthopedics Corporation |
II |
Aug-12-2020 |
9 |
GRAMERCY EXTREMITY ORTHOPEDICS |
II |
Apr-17-2023 |
10 |
I.T.S. GmbH |
II |
Jun-04-2019 |
11 |
K2M, Inc |
II |
Apr-12-2021 |
12 |
Miami Device Solutions, LLC. |
II |
Dec-05-2019 |
13 |
NewDeal SA |
II |
Jul-16-2018 |
14 |
Nextremity Solutions |
II |
Feb-11-2020 |
15 |
Nextremity Solutions |
II |
Nov-22-2019 |
16 |
Orthofix, Inc |
II |
Jun-07-2018 |
17 |
Paragon 28, Inc. |
II |
Jul-25-2022 |
18 |
Smith & Nephew, Inc. |
II |
Feb-01-2022 |
19 |
Smith & Nephew, Inc. |
II |
Dec-10-2021 |
20 |
Smith & Nephew, Inc. |
II |
Nov-18-2021 |
21 |
Smith & Nephew, Inc. |
II |
Sep-09-2020 |
22 |
Smith & Nephew, Inc. |
II |
Jan-24-2018 |
23 |
Smith & Nephew, Inc. |
II |
Jan-19-2018 |
24 |
Stryker GmbH |
II |
Jan-07-2020 |
25 |
Synthes (USA) Products LLC |
II |
Mar-01-2024 |
26 |
Synthes (USA) Products LLC |
II |
Aug-17-2020 |
27 |
Synthes, Inc. |
II |
Jan-29-2020 |
28 |
Toby Orthopaedics, Inc. |
II |
Dec-04-2019 |
29 |
Treace Medical Concepts, Inc. |
II |
Aug-23-2024 |
30 |
TriMed Inc. |
II |
Jan-31-2024 |
31 |
TriMed Inc. |
II |
Nov-13-2019 |
32 |
TriMed Inc. |
II |
Oct-10-2019 |
33 |
TriMed Inc. |
II |
Apr-23-2019 |
34 |
TriMed Inc. |
II |
Aug-18-2018 |
35 |
Wishbone Medical, Inc. |
II |
Jun-04-2021 |
36 |
Wright Medical Technology Inc |
II |
Dec-17-2021 |
37 |
Wright Medical Technology, Inc. |
II |
Apr-26-2023 |
38 |
Wright Medical Technology, Inc. |
II |
Feb-24-2023 |
39 |
Wright Medical Technology, Inc. |
II |
Mar-15-2022 |
40 |
Wright Medical Technology, Inc. |
II |
Feb-25-2022 |
41 |
Wright Medical Technology, Inc. |
II |
Dec-20-2021 |
42 |
Wright Medical Technology, Inc. |
II |
Nov-25-2019 |
43 |
Zimmer Biomet, Inc. |
II |
Nov-07-2019 |
44 |
Zimmer Biomet, Inc. |
II |
Aug-31-2018 |
45 |
Zimmer Biomet, Inc. |
II |
Apr-03-2018 |
46 |
Zimmer, Inc. |
II |
Jul-28-2023 |
|
|
|
|