Clearance Summary
FASICULATED NAIL received FDA 510(k) clearance under submission number K861365, sponsored by Lake Region Mfg., 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 1986-05-06.
- Submission: K861365
- Applicant / Sponsor: Lake Region Mfg., Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3020
- Decision date: 1986-05-06
Classification & Regulation
This clearance is catalogued under FDA product code HSB and 21 CFR 888.3020, within the Orthopedic review panel as a Class II device.