Clearance Summary
FIXIT / ComposiTCP Threaded Anchor System received FDA 510(k) clearance under submission number K180960, sponsored by S.B.M. Sas Sciences For Bio Materials. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2018-07-25.
- Submission: K180960
- Applicant / Sponsor: S.B.M. Sas Sciences For Bio Materials
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2018-07-25
Classification & Regulation
This clearance is catalogued under FDA product code MAI and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.