K050138 is an FDA 510(k) clearance for the MODIFICATION TO: RESTORATION MODULAR SYSTEM. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II - Special Controls, product code JDI).
Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on March 21, 2005, 59 days after receiving the submission on January 21, 2005.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3350.
| 510(k) Number | K050138 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2005 |
| Decision Date | March 21, 2005 |
| Days to Decision | 59 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | JDI — Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3350 |