The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Omnifit (tm) Total Knee Prosthesis System.
| Device ID | K863668 |
| 510k Number | K863668 |
| Device Name: | OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/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 | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-18 |
| Decision Date | 1986-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327033823 | K863668 | 000 |
| 07613327033809 | K863668 | 000 |
| 07613327033793 | K863668 | 000 |
| 07613327033779 | K863668 | 000 |