The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Kinemax(r) Condylar Total Knee Syst Femoral Spacer.
| Device ID | K925901 |
| 510k Number | K925901 |
| Device Name: | KINEMAX(R) CONDYLAR TOTAL KNEE SYST FEMORAL SPACER |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Robert E Smith |
| Correspondent | Robert E Smith HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-20 |
| Decision Date | 1993-03-22 |