Device Classification Name |
shoulder prosthesis, reverse configuration
|
510(k) Number |
K141006 |
Device Name |
RSP HUMERAL SOCKET INSERT |
Applicant |
DJO GLOBAL |
9800 METRIC BOULEVARD |
AUSTIN,
TX
78758
|
|
Applicant Contact |
CHRISTINE CHESNUTT |
Correspondent |
DJO GLOBAL |
9800 METRIC BOULEVARD |
AUSTIN,
TX
78758
|
|
Correspondent Contact |
CHRISTINE CHESNUTT |
Regulation Number | 888.3660
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/18/2014 |
Decision Date | 06/05/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|