The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Omnifit Total Knee Prosthesis System.
| Device ID | K862837 |
| 510k Number | K862837 |
| Device Name: | OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Dennis H Crane |
| Correspondent | Dennis H Crane OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-25 |
| Decision Date | 1986-12-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327033939 | K862837 | 000 |
| 07613327033922 | K862837 | 000 |