Clearance Summary
OsteoCoil GT Active Compression System received FDA 510(k) clearance under submission number K260106, sponsored by Flower Orthopedics Corporation DBA Conventus Flower Orthoped. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2026-08-24.
- Submission: K260106
- Applicant / Sponsor: Flower Orthopedics Corporation DBA Conventus Flower Orthoped
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2026-08-24
Classification & Regulation
This clearance is catalogued under FDA product code HWC and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.