Device Classification Name |
prosthesis, shoulder, semi-constrained, metal/polymer cemented
|
510(k) Number |
K142403 |
Device Name |
Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System |
Applicant |
ZIMMER GMBH |
SULZERALLEE 8 |
WINTERTHUR,
CH
8404
|
|
Applicant Contact |
Roberto Tommasini |
Correspondent |
ZIMMER GMBH |
SULZERALLEE 8 |
WINTERTHUR,
CH
8404
|
|
Correspondent Contact |
Annemie Rehor Kausch |
Regulation Number | 888.3660
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/27/2014 |
Decision Date | 11/24/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|