Device Classification Name |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
|
510(k) Number |
K193038 |
Device Name |
Comprehensive Shoulder System |
Applicant |
Biomet Manufacturing Corp. |
56 East Bell Drive |
Warsaw,
IN
46580
|
|
Applicant Contact |
Patricia Sandborn Beres |
Correspondent |
Biomet Manufacturing Corp. |
56 East Bell Drive |
Warsaw,
IN
46580
|
|
Correspondent Contact |
Patricia Sandborn Beres |
Regulation Number | 888.3670
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/31/2019 |
Decision Date | 10/28/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|