Device Classification Name |
shoulder prosthesis, reverse configuration
|
510(k) Number |
K130895 |
Device Name |
REUNION RSA SHOULDER SYSTEM |
Applicant |
HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. |
MAHWAH,
NJ
07430
|
|
Applicant Contact |
ESTELA CELI |
Correspondent |
HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. |
MAHWAH,
NJ
07430
|
|
Correspondent Contact |
ESTELA CELI |
Regulation Number | 888.3660
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/01/2013 |
Decision Date | 12/27/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|