The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Gap-ii Restoration Acetabular Shells.
| Device ID | K980774 |
| 510k Number | K980774 |
| Device Name: | OSTEONICS GAP-II RESTORATION ACETABULAR SHELLS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| 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 | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-02 |
| Decision Date | 1998-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327017656 | K980774 | 000 |
| 07613327017533 | K980774 | 000 |
| 07613327017540 | K980774 | 000 |
| 07613327017557 | K980774 | 000 |
| 07613327017564 | K980774 | 000 |
| 07613327017571 | K980774 | 000 |
| 07613327017588 | K980774 | 000 |
| 07613327017595 | K980774 | 000 |
| 07613327017601 | K980774 | 000 |
| 07613327017618 | K980774 | 000 |
| 07613327017625 | K980774 | 000 |
| 07613327017632 | K980774 | 000 |
| 07613327017649 | K980774 | 000 |
| 07613327017526 | K980774 | 000 |