|
Device |
prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
Product Code | KWY |
Regulation Number |
888.3390
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
BIOPRO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORENTEC CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORIN USA LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEPUY FRANCE S.A.S. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEPUY IRELAND UC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
G21, S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HERAEUS MEDICAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
IMPLANTCAST, GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMPLANTS INTERNATIONAL, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KYOCERA MEDICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDACTA INTERNATIONAL, SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OMNI LIFE SCIENCE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OMNLIFE SCIENCE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ONKOS SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RENOVIS SURGICAL TECHNOLOGIES LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIGNATURE ORTHOPAEDICS PTY LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SURGTECH, INC., |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TGM MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THEKEN COMPANIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOTAL JOINT ORTHOPEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNITED ORTHOPEDIC CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNITED ORTHOPEDIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WALDEMAR LINK GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Biomet, Inc. |
II |
Apr-03-2020 |
2 |
Exactech, Inc. |
II |
Jun-28-2024 |
3 |
Omni Life Science |
II |
Sep-10-2009 |
4 |
Ortho Development Corporation |
II |
Aug-17-2014 |
5 |
Ortho Development Corporation |
II |
Nov-03-2010 |
6 |
Ortho Development Corporation |
II |
Oct-28-2009 |
7 |
Orthopedic Alliance LLC |
II |
May-24-2013 |
8 |
Smith & Nephew, Inc. |
II |
Nov-03-2016 |
9 |
Zimmer Biomet, Inc. |
II |
Nov-22-2019 |
10 |
Zimmer Biomet, Inc. |
II |
Nov-07-2018 |
11 |
Zimmer Biomet, Inc. |
II |
Mar-14-2018 |
12 |
Zimmer Biomet, Inc. |
II |
Feb-15-2018 |
13 |
Zimmer Biomet, Inc. |
II |
Feb-22-2016 |
14 |
Zimmer Manufacturing B.V. |
II |
Mar-12-2016 |
15 |
Zimmer, Inc. |
II |
Feb-20-2014 |
16 |
Zimmer, Inc. |
II |
Oct-25-2013 |
17 |
Zimmer, Inc. |
II |
Nov-20-2012 |
|
|
|
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