K063550 is an FDA 510(k) clearance for the SYSTEM 12 CONSTRAINED ACETABULAR LINERS. This device is classified as a Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer (Class II - Special Controls, product code KWZ).
Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on March 8, 2007, 104 days after receiving the submission on November 24, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3310.
| 510(k) Number | K063550 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2006 |
| Decision Date | March 08, 2007 |
| Days to Decision | 104 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 |