Clearance Summary
HEX-FIX FIELD FIXATOR received FDA 510(k) clearance under submission number K953397, sponsored by Smith & Nephew Richards, 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 1995-10-31.
- Submission: K953397
- Applicant / Sponsor: Smith & Nephew Richards, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 1995-10-31
Classification & Regulation
This clearance is catalogued under FDA product code LXT and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.