K250760 is an FDA 510(k) clearance for the SPECTRUM GV Bone Cement. This device is classified as a Bone Cement (Class II - Special Controls, product code LOD).
Submitted by Osteoremedies, LLC (Memphis, US). The FDA issued a Cleared decision on April 2, 2025, 20 days after receiving the submission on March 13, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K250760 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 13, 2025 |
| Decision Date | April 02, 2025 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LOD - Bone Cement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3027 |