The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Restoration Acetabular Ring.
| Device ID | K970957 |
| 510k Number | K970957 |
| Device Name: | OSTEONICS RESTORATION ACETABULAR RING |
| Classification | Mesh, Surgical, Acetabular, Hip, Prosthesis |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Kate Sutton |
| Correspondent | Kate Sutton OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | JDJ |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-17 |
| Decision Date | 1997-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327017731 | K970957 | 000 |
| 07613327017724 | K970957 | 000 |
| 07613327017700 | K970957 | 000 |
| 07613327017694 | K970957 | 000 |
| 07613327017687 | K970957 | 000 |
| 07613327017670 | K970957 | 000 |
| 07613327017663 | K970957 | 000 |