The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Restoration Acetabular Cup.
| Device ID | K943549 |
| 510k Number | K943549 |
| Device Name: | RESTORATION ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Robert A Koch |
| Correspondent | Robert A Koch OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-21 |
| Decision Date | 1994-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327037173 | K943549 | 000 |
| 07613327037098 | K943549 | 000 |
| 07613327037104 | K943549 | 000 |
| 07613327037111 | K943549 | 000 |
| 07613327037128 | K943549 | 000 |
| 07613327037135 | K943549 | 000 |
| 07613327037142 | K943549 | 000 |
| 07613327037159 | K943549 | 000 |
| 07613327037166 | K943549 | 000 |
| 07613327037081 | K943549 | 000 |