The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics All Polyethylene Glenoid Shoulder Component.
| Device ID | K950521 |
| 510k Number | K950521 |
| Device Name: | OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Terry Jarosz |
| Correspondent | Terry Jarosz OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-06 |
| Decision Date | 1995-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327138214 | K950521 | 000 |
| 07613327138207 | K950521 | 000 |
| 07613327138191 | K950521 | 000 |
| 07613327138153 | K950521 | 000 |