The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Special Orthopaedic Solutions Glenoid Shoulder Component.
| Device ID | K103104 |
| 510k Number | K103104 |
| Device Name: | SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Avital Merl-margulies |
| Correspondent | Avital Merl-margulies HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-20 |
| Decision Date | 2010-11-22 |
| Summary: | summary |