Device Classification Name |
prosthesis, shoulder, semi-constrained, metal/polymer cemented
|
510(k) Number |
K160085 |
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 | 01/15/2016 |
Decision Date | 03/08/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|