K803235 is an FDA 510(k) clearance for the GEO-TIBIAL RETAINER ROTATIONAL. This device is classified as a Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (Class II - Special Controls, product code HSX).
Submitted by Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1981, 44 days after receiving the submission on December 22, 1980.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3520.
| 510(k) Number | K803235 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1980 |
| Decision Date | February 04, 1981 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HSX — Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3520 |