Clearance Summary
STABLELOC II EXTERNAL FIXATOR received FDA 510(k) clearance under submission number K965029, 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 1997-02-19.
- Submission: K965029
- Applicant / Sponsor: Acu Med, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 1997-02-19
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.