510(k) K241468
K241468 is an FDA 510(k) premarket notification submitted by Foundation Surgical Group, Inc. for the device "Vertiwedge® Intraosseous System". The FDA issued a decision of Substantially Equivalent on November 7, 2024. 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, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 2024
- Date Received
- May 24, 2024
- Clearance Type
- Traditional
- 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