Device Classification Name |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
|
510(k) Number |
K103104 |
Device Name |
SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT |
Applicant |
HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. |
MAHWAH,
NJ
07430
|
|
Applicant Contact |
AVITAL MERL-MARGULIES |
Correspondent |
HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. |
MAHWAH,
NJ
07430
|
|
Correspondent Contact |
AVITAL MERL-MARGULIES |
Regulation Number | 888.3660
|
Classification Product Code |
|
Date Received | 10/20/2010 |
Decision Date | 11/22/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|