|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
competitor unicondylar all-poly tibial baseplate
|
SMITH & NEPHEW, INC.
|
K061779 |
08/04/2006
|
competitor unicondylar knee tibial baseplate
|
SMITH & NEPHEW, INC.
|
K061011 |
07/11/2006
|
genesis unicondylar uhmwpe articular inserts
|
SMITH & NEPHEW, INC.
|
K100197 |
02/19/2010
|
journey ii uni tibial base and insert
|
Smith & Nephew, Inc.
|
K152315 |
10/28/2015
|
journey ii unicompartmental knee system
|
Smith & Nephew, Inc.
|
K191211 |
07/25/2019
|
journey unicondylar femoral implant
|
SMITH & NEPHEW, INC.
|
K073175 |
12/20/2007
|
journey unicondylar tibial baseplates
|
SMITH & NEPHEW, INC.
|
K102069 |
10/05/2010
|
modification to journey unicondylar femoral implant
|
SMITH & NEPHEW, INC.
|
K081351 |
07/24/2008
|
smith & nephew inc. unicompartmental and biocompartmental knee system instruments
|
SMITH & NEPHEW, INC.
|
K113038 |
01/05/2012
|
smith & nephew, inc. anthem total knee system, genesis uni knee system, journey bcs and ii knee systems, journey ii cr knee system, journey ii uni knee system, journey ii uk knee system, journey ii xr bi-cruciate retaining knee system, journey pfj system, journey uni knee system, legion hinge total
|
Smith & Nephew, Inc.
|
K230653 |
05/04/2023
|
|