510(k) clearance
F.A.S.T Screw
- 510(k) number
- K254280
- Applicant
- Steps Ortho
- Decision date
- Sep 21, 2026
- Date received
- Dec 30, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- HWC
- Device type
- Screw, Fixation, Bone
- Device class
- Class II
- Regulation
- 21 CFR 888.3040
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Bron, FR