Clearance Summary
MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER received FDA 510(k) clearance under submission number K821695, sponsored by Micro-Aire Surgical Instruments, 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 1982-07-20.
- Submission: K821695
- Applicant / Sponsor: Micro-Aire Surgical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1982-07-20
Classification & Regulation
This clearance is catalogued under FDA product code HTT and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.