510(k) K242091
K242091 is an FDA 510(k) premarket notification submitted by Fusion Orthopedics for the device "Bolo Button System". The FDA issued a decision of Substantially Equivalent on December 23, 2024. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. Fusion Orthopedics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 2024
- Date Received
- July 17, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Washer, Bolt Nut
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type