The following data is part of a premarket notification filed by Implantology Corp. with the FDA for Crk Condylar Resurfacing Total Knee.
| Device ID | K915584 |
| 510k Number | K915584 |
| Device Name: | CRK CONDYLAR RESURFACING TOTAL KNEE |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | IMPLANTOLOGY CORP. 11 OAK LN. Pine Brook, NJ 07058 |
| Contact | Mark Forte |
| Correspondent | Mark Forte IMPLANTOLOGY CORP. 11 OAK LN. Pine Brook, NJ 07058 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-13 |
| Decision Date | 1993-02-12 |