K790762 is an FDA 510(k) clearance for the PLATFORM TCCK TOTAL KNEE. This device is classified as a Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (Class II - Special Controls, product code HRY).
Submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 14, 1979, 27 days after receiving the submission on April 17, 1979.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3530.
| 510(k) Number | K790762 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 1979 |
| Decision Date | May 14, 1979 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HRY — Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3530 |