|
Device |
appliance, fixation, nail/blade/plate combination, multiple component |
Product Code | KTT |
Regulation Number |
888.3030
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ACUTE INNOVATIONS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AESCULAP IMPLANT SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AIKE (SHANGHAI) MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANGLEFIX |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARROWHEAD DE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ARTHREX INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASCENSION ORTHOPEDIC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASCENSION ORTHOPEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AUSTIN MILLER TRAUMA LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AUXEIN MEDICAL PRIVATE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMET TRAUMA (AKA EBI LLC) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BK MEDITECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDINAL HEALTH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CITIEFFE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CITIEFFE S.R.L |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CITIEFFE S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
D.N.E., LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DEPUY ORTHOPAEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DEPUY SYNTHES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DEVISE ORTHO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DNE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EBI, L.P. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EBI, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EMERGE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXTRAORTHO INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXTRAORTHO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GEXFIX INTERNATIONAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBUS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLW MEDICAL INNOVATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HNM TOTAL RECON, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOWMEDICA OSTEONICS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JEIL MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JOHN J RICCIO |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIFE SPINE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MDPO, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERETE MEDICAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERETE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEW STANDARD DEVICE DBA METALOGIX |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NUTEK ORTHOPAEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOFIX SRL |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
ORTHONOVIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOPAEDIC DEVICE RESEARCH CENTER |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOPAEDIC IMPLANT COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ORTHOPEDIATRICS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORTHOSPIN |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOSPIN LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARAGON 28, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARAGON 28, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PEGA MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QFX TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QUANTUM MEDICAL CONCEPTS, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
RENOVIS SURGICAL TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
S H PITKAR ORTHOTOOLS PVT LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
S H PITKAR ORTHOTOOLS PVT LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SEQUEL MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMALL BONE INNOVATIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
STERILMED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
STRYKER GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
STRYKER SUSTAINABILITY SOLUTIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER TRAUMA AG |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SURGICAL IMPLANT GENERATION NETWORK (SIGN) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SYNTHES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNTHES (USA) |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SYNTHES (USA) PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SYNTHES USA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TASARIMMED TIBBI MAMULLER SANAYI VE TICARET A.S |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TECHNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TECNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THE ORTHOPAEDIC IMPLANT COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VILEX IN TENNESSEE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VILEX LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VILEX, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WISHBONE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
WRIGHT MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WRIGHT MEDICAL TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
ZIMMER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Biomet, Inc. |
II |
May-26-2016 |
2 |
Biomet, Inc. |
II |
Jun-09-2015 |
3 |
Biomet, Inc. |
II |
Dec-17-2012 |
4 |
Howmedica Osteonics Corp. |
II |
Feb-16-2022 |
5 |
Integra LifeSciences Corp. |
II |
Aug-11-2016 |
6 |
Integra LifeSciences Corp. |
II |
Jul-27-2016 |
7 |
Kinamed Inc |
II |
Jun-17-2011 |
8 |
Medicalplastic S.R.L. |
II |
Nov-17-2021 |
9 |
New Standard Device Inc |
II |
Jun-09-2023 |
10 |
New Standard Device Inc |
II |
Aug-29-2022 |
11 |
New Standard Device Inc |
II |
Jun-03-2022 |
12 |
OrthoPediatrics Corp |
II |
Sep-06-2022 |
13 |
Orthofix Srl |
II |
Nov-14-2019 |
14 |
Orthofix Srl |
II |
Jun-05-2018 |
15 |
Orthofix Srl |
II |
Dec-27-2017 |
16 |
Small Bone Innovations, Inc. |
II |
Jun-04-2014 |
17 |
Sterilmed Inc |
II |
Jan-13-2009 |
18 |
Stryker GmbH |
II |
Mar-01-2023 |
19 |
Stryker GmbH |
II |
Oct-29-2018 |
20 |
Stryker GmbH |
II |
Sep-22-2018 |
21 |
Stryker GmbH |
II |
Apr-26-2018 |
22 |
Stryker Howmedica Osteonics Corp. |
II |
May-25-2017 |
23 |
Stryker Howmedica Osteonics Corp. |
II |
Jan-17-2013 |
24 |
Stryker Howmedica Osteonics Corp. |
II |
Nov-08-2012 |
25 |
Stryker Howmedica Osteonics Corp. |
II |
Aug-18-2009 |
26 |
Synthes (USA) Products LLC |
II |
Aug-24-2015 |
27 |
Synthes Spine |
II |
May-29-2009 |
28 |
Synthes USA HQ, Inc. |
II |
Dec-10-2013 |
29 |
Synthes USA HQ, Inc. |
II |
Nov-27-2013 |
30 |
Synthes USA HQ, Inc. |
II |
Sep-25-2013 |
31 |
Synthes USA HQ, Inc. |
II |
Jul-29-2013 |
32 |
Synthes USA HQ, Inc. |
II |
Mar-11-2013 |
33 |
Synthes USA HQ, Inc. |
II |
Nov-13-2012 |
34 |
Synthes, Inc. |
II |
Jun-19-2014 |
35 |
Wishbone Medical, Inc. |
II |
Feb-07-2023 |
36 |
Zimmer Biomet, Inc. |
II |
Nov-22-2019 |
37 |
Zimmer Biomet, Inc. |
II |
Nov-07-2019 |
38 |
Zimmer Biomet, Inc. |
II |
Jun-15-2017 |
39 |
Zimmer Manufacturing B.V. |
II |
May-16-2016 |
40 |
Zimmer Manufacturing B.V. |
II |
Mar-12-2016 |
41 |
Zimmer, Inc. |
II |
Feb-20-2014 |
42 |
Zimmer, Inc. |
II |
Aug-26-2013 |
|
|
|
|