Clearance Summary
CERCLAGE WIRE CRIMP BLOCK received FDA 510(k) clearance under submission number K960651, sponsored by Acu-Med, 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 1996-05-03.
- Submission: K960651
- Applicant / Sponsor: Acu-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3010
- Decision date: 1996-05-03
Classification & Regulation
This clearance is catalogued under FDA product code JDQ and 21 CFR 888.3010, within the Orthopedic review panel as a Class II device.