K033953 is an FDA 510(k) clearance for the OPTIMESH 500E CEMENT RESTRICTOR. This device is classified as a Prosthesis, Hip, Cement Restrictor (Class II - Special Controls, product code JDK).
Submitted by Spineology, Inc. (Stillwater, US). The FDA issued a Cleared decision on July 6, 2004, 197 days after receiving the submission on December 22, 2003.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K033953 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | December 22, 2003 |
| Decision Date | July 06, 2004 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDK — Prosthesis, Hip, Cement Restrictor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |