The following data is part of a premarket notification filed by Osteonics Reconstructive Products Div. with the FDA for Osteonics Sr Glenoid Components.
| Device ID | K903886 |
| 510k Number | K903886 |
| Device Name: | OSTEONICS SR GLENOID COMPONENTS |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | OSTEONICS RECONSTRUCTIVE PRODUCTS DIV. 59 ROUTE 17 Allendale, NJ 07401 |
| Contact | Pat Kramer |
| Correspondent | Pat Kramer OSTEONICS RECONSTRUCTIVE PRODUCTS DIV. 59 ROUTE 17 Allendale, NJ 07401 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-22 |
| Decision Date | 1990-11-20 |