510(k) K261810
K261810 is an FDA 510(k) premarket notification submitted by Foundation Surgical Group for the device "Vertiwedge® Intraosseous System". The FDA issued a decision of Substantially Equivalent on Jul 31, 2026. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Foundation Surgical Group has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 31, 2026
- Date Received
- Jun 1, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spinal Vertebral Body Replacement Device
- Device Class
- Class II
- Regulation Number
- 888.3060
- Review Panel
- OR
- Submission Type
- 510(k)