Device Classification Name |
shoulder prosthesis, reverse configuration
|
510(k) Number |
K193373 |
Device Name |
Comprehensive® Reverse Shoulder |
Applicant |
Biomet Inc. |
56 East Bell Drive, PO Box 587 |
Warsaw,
IN
46581
|
|
Applicant Contact |
Kari Hovorka |
Correspondent |
Biomet Inc. |
56 East Bell Drive, PO Box 587 |
Warsaw,
IN
46581
|
|
Correspondent Contact |
Kari Hovorka |
Regulation Number | 888.3660
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/05/2019 |
Decision Date | 04/15/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|