K050637 is an FDA 510(k) clearance for the ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II - Special Controls, product code JDI).
Submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on September 23, 2005, 196 days after receiving the submission on March 11, 2005.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3350.
| 510(k) Number | K050637 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 2005 |
| Decision Date | September 23, 2005 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| 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 |