Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K160553 |
Device Name |
DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless S |
Applicant |
SYNTHES (USA) PRODUCTS LLC/DEPUY ORTHOPAEDICS INC |
1301 GOSHEN PARKWAY |
WEST CHESTER,
PA
19380
|
|
Applicant Contact |
ELIZABETH JACOBS |
Correspondent |
SYNTHES (USA) PRODUCTS LLC/DEPUY ORTHOPAEDICS INC |
1301 GOSHEN PARKWAY |
WEST CHESTER,
PA
19380
|
|
Correspondent Contact |
ELIZABETH JACOBS |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/29/2016 |
Decision Date | 06/30/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|