K033883 is an FDA 510(k) clearance for the OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABI. 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 February 13, 2004, 60 days after receiving the submission on December 15, 2003.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3560.
| 510(k) Number | K033883 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2003 |
| Decision Date | February 13, 2004 |
| Days to Decision | 60 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3560 |