Clearance Summary
OTI EUROPEAN COMPRESSION SYSTEM received FDA 510(k) clearance under submission number K925571, sponsored by Osteo-Technology Intl., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1993-07-13.
- Submission: K925571
- Applicant / Sponsor: Osteo-Technology Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 1993-07-13
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.