Clearance Summary
GARDNER PINS (ADULT & CHILD) received FDA 510(k) clearance under submission number K911772, sponsored by Codman & Shurtleff, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1991-08-26.
- Submission: K911772
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4460
- Decision date: 1991-08-26
Classification & Regulation
This clearance is catalogued under FDA product code HBL and 21 CFR 882.4460, within the Neurology review panel as a Class II device.