K241468 is an FDA 510(k) clearance for the Vertiwedge® Intraosseous System. This device is classified as a Spinal Vertebral Body Replacement Device (Class II - Special Controls, product code MQP).
Submitted by Foundation Surgical Group, Inc. (Scottsdale, US). The FDA issued a Cleared decision on November 7, 2024, 167 days after receiving the submission on May 24, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K241468 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 2024 |
| Decision Date | November 07, 2024 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MQP - Spinal Vertebral Body Replacement Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3060 |