K082022 is an FDA 510(k) clearance for the OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++. 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 September 2, 2008, 48 days after receiving the submission on July 16, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3560.
| 510(k) Number | K082022 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2008 |
| Decision Date | September 02, 2008 |
| Days to Decision | 48 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 |