Clearance Summary
TRUE/LOK MONOLATERAL/BILATERAL FIXATOR received FDA 510(k) clearance under submission number K941048, sponsored by Applied Osteo Systems, 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 1994-10-03.
- Submission: K941048
- Applicant / Sponsor: Applied Osteo Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 1994-10-03
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.