K083566 is an FDA 510(k) clearance for the R3 CONSTRAINED LINER, CONSTRAINED LINER. This device is classified as a Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer (Class II - Special Controls, product code KWZ).
Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on March 3, 2009, 90 days after receiving the submission on December 3, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3310.
| 510(k) Number | K083566 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2008 |
| Decision Date | March 03, 2009 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3310 |