Clearance Summary
LIMA-LTO ECS EXTERNAL CIRCULAR STABILIZER received FDA 510(k) clearance under submission number K881673, sponsored by Lima-Lto, 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 1988-06-03.
- Submission: K881673
- Applicant / Sponsor: Lima-Lto, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 1988-06-03
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.