Clearance Summary
FR.O.H. CALCANEUS REPAIR SYSTEM received FDA 510(k) clearance under submission number K051642, sponsored by I.T.S. Implantat-Technologie-Systeme GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2005-08-22.
- Submission: K051642
- Applicant / Sponsor: I.T.S. Implantat-Technologie-Systeme GmbH
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2005-08-22
Classification & Regulation
This clearance is catalogued under FDA product code NDF and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.