|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
tandem hip system
|
Smith & Nephew, Inc.
|
K231448 |
07/19/2023
|
smith & nephew hip systems
|
Smith & Nephew, Inc.
|
K211176 |
07/01/2022
|
polarstem calcar reamer guide
|
Smith & Nephew, Inc.
|
K211548 |
07/19/2021
|
redapt porous acetabular shell
|
Smith & Nephew, Inc.
|
K181366 |
09/24/2018
|
birmingham hip (bh) dual mobility insert
|
Smith & Nephew, Inc.
|
K171934 |
11/30/2017
|
polarstem collared (standard and lateral) and valgus femoral stem with ti/ha
|
SMITH & NEPHEW, INC.
|
K143739 |
04/20/2015
|
sl-plus mia and sl-plus femoral stems with ti/ha
|
Smith & Nephew, Inc.
|
K143096 |
03/24/2015
|
smith & nephew global femoral head trials
|
SMITH & NEPHEW, INC.
|
K132435 |
10/22/2013
|
polarstem standard and lateral femoral stems with ti/ha
|
SMITH & NEPHEW, INC.
|
K130728 |
10/10/2013
|
smith & nephew, inc. hip system instrumentation
|
SMITH & NEPHEW, INC.
|
K123598 |
06/28/2013
|
|