|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
competitor unicondylar knee tibial baseplate
|
SMITH & NEPHEW, INC.
|
K061011 |
07/11/2006
|
competitor unicondylar all-poly tibial baseplate
|
SMITH & NEPHEW, INC.
|
K061779 |
08/04/2006
|
journey unicondylar femoral implant
|
SMITH & NEPHEW, INC.
|
K073175 |
12/20/2007
|
modification to journey unicondylar femoral implant
|
SMITH & NEPHEW, INC.
|
K081351 |
07/24/2008
|
smith & nephew, inc. journey select knee system
|
SMITH & NEPHEW, INC.
|
K093056 |
12/15/2009
|
genesis unicondylar uhmwpe articular inserts
|
SMITH & NEPHEW, INC.
|
K100197 |
02/19/2010
|
journey unicondylar tibial baseplates
|
SMITH & NEPHEW, INC.
|
K102069 |
10/05/2010
|
smith & nephew inc. unicompartmental and biocompartmental knee system instruments
|
SMITH & NEPHEW, INC.
|
K113038 |
01/05/2012
|
smith & nephew, inc. total knee system instrumentation
|
SMITH & NEPHEW, INC.
|
K121393 |
08/07/2012
|
journey ii uni tibial base and insert
|
Smith & Nephew, Inc.
|
K152315 |
10/28/2015
|
|