Clearance Summary
HALL DUNBAR DRILL GUIDE SYSTEM received FDA 510(k) clearance under submission number K864163, sponsored by Hall Surgical, Division of Zimmer, 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 1986-11-20.
- Submission: K864163
- Applicant / Sponsor: Hall Surgical, Division of Zimmer, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 1986-11-20
Classification & Regulation
This clearance is catalogued under FDA product code HRX and 21 CFR 888.1100, within the Orthopedic review panel as a Class II device.