510(k) K240084
K240084 is an FDA 510(k) premarket notification submitted by Hyprevention for the device "V-STRUT® Vertebral Implant". The FDA issued a decision of Substantially Equivalent on February 9, 2024. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027. Hyprevention has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 2024
- Date Received
- January 11, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement, Bone, Vertebroplasty
- Device Class
- Class II
- Regulation Number
- 888.3027
- Review Panel
- OR
- Submission Type