The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Unix Unicompartmental.
| Device ID | K923011 |
| 510k Number | K923011 |
| Device Name: | OSTEONICS UNIX UNICOMPARTMENTAL |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| 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 | HRY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-22 |
| Decision Date | 1993-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327101522 | K923011 | 000 |
| 07613327101386 | K923011 | 000 |
| 07613327101393 | K923011 | 000 |
| 07613327101409 | K923011 | 000 |
| 07613327101416 | K923011 | 000 |
| 07613327101423 | K923011 | 000 |
| 07613327101430 | K923011 | 000 |
| 07613327101447 | K923011 | 000 |
| 07613327101454 | K923011 | 000 |
| 07613327101461 | K923011 | 000 |
| 07613327101478 | K923011 | 000 |
| 07613327101485 | K923011 | 000 |
| 07613327101492 | K923011 | 000 |
| 07613327101508 | K923011 | 000 |
| 07613327101515 | K923011 | 000 |
| 07613327101379 | K923011 | 000 |