K933610 is an FDA 510(k) clearance for the EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS. This device is classified as a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II - Special Controls, product code JWH).
Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on January 17, 1995, 539 days after receiving the submission on July 27, 1993.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3560.
| 510(k) Number | K933610 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | July 27, 1993 |
| Decision Date | January 17, 1995 |
| Days to Decision | 539 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3560 |