Clearance Summary
KLSA MARTIN HAND DISTRACTOR received FDA 510(k) clearance under submission number K042066, sponsored by KLS-Martin L.P.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2004-08-25.
- Submission: K042066
- Applicant / Sponsor: KLS-Martin L.P.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2004-08-25
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.