Clearance Summary
SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE received FDA 510(k) clearance under submission number K091207, sponsored by Surgicraft , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2011-02-15.
- Submission: K091207
- Applicant / Sponsor: Surgicraft , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2011-02-15
Classification & Regulation
This clearance is catalogued under FDA product code HTN and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.