K873429 is an FDA 510(k) clearance for the FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE. This device is classified as a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer (Class II - Special Controls, product code MBV).
Submitted by Protek, Inc. (Indianapolis, US). The FDA issued a Cleared decision on October 28, 1987, 64 days after receiving the submission on August 25, 1987.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3560.
| 510(k) Number | K873429 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 1987 |
| Decision Date | October 28, 1987 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | MBV — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3560 |