K945028 is an FDA 510(k) clearance for the FINN KNEE SYSTEM. This device is classified as a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (Class II - Special Controls, product code KRO).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 14, 1996, 489 days after receiving the submission on October 13, 1994.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3510.
| 510(k) Number | K945028 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | October 13, 1994 |
| Decision Date | February 14, 1996 |
| Days to Decision | 489 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3510 |