The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for M.c.r. Knee Prosthesis (series 3000).
| Device ID | K860654 |
| 510k Number | K860654 |
| Device Name: | M.C.R. KNEE PROSTHESIS (SERIES 3000) |
| 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 | 1986-02-21 |
| Decision Date | 1986-03-14 |