Clearance Summary
FRACTURE REDUCTION SYS., MODEL OR 1001 received FDA 510(k) clearance under submission number K770388, sponsored by Sisan Assoc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1977-03-14.
- Submission: K770388
- Applicant / Sponsor: Sisan Assoc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 1977-03-14
Classification & Regulation
This clearance is catalogued under FDA product code JEC and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.