Device Classification Name |
Shoulder Prosthesis, Reverse Configuration
|
510(k) Number |
K172767 |
Device Name |
Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid |
Applicant |
Zimmer, Inc. |
345 East Main Street |
Warsaw,
IN
46580
|
|
Applicant Contact |
Ehab Esmail |
Correspondent |
Zimmer, Inc. |
56 East Bell Drive |
Warsaw,
IN
46581
|
|
Correspondent Contact |
Andrew Steward |
Regulation Number | 888.3660
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/13/2017 |
Decision Date | 11/30/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|