Device Classification Name |
prosthesis, shoulder, hemi-, humeral, metallic uncemented
|
510(k) Number |
K161620 |
Device Name |
Anatomical Shoulder Domelock Dome centric |
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 | 888.3690
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/13/2016 |
Decision Date | 11/01/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|