Bolo Button System
510(k) K242091
Bolo Button System is a Class II device made by Fusion Orthopedics, cleared under FDA 510(k) K242091 on 23 Dec 2024, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK242091 | Date23 Dec 2024 | StatusActive |
Official records
- FDA 510(k) database K242091
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HTN
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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- KAPP SPINAL BUTTON by Kapp Surgical Instrument, Inc.