K002652 is an FDA 510(k) clearance for the SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII. This device is classified as a Bone Cement (Class II - Special Controls, product code LOD).
Submitted by Stryker Corp. (Portage, US). The FDA issued a Cleared decision on January 26, 2001, 154 days after receiving the submission on August 25, 2000.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K002652 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2000 |
| Decision Date | January 26, 2001 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | LOD — Bone Cement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3027 |