K082567 is an FDA 510(k) clearance for the STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION. This device is classified as a Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (Class II - Special Controls, product code HRY).
Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on October 3, 2008, 29 days after receiving the submission on September 4, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3530.
| 510(k) Number | K082567 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2008 |
| Decision Date | October 03, 2008 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HRY — Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3530 |