Clearance Summary
BENDEREV DRILL GUIDE received FDA 510(k) clearance under submission number K923776, sponsored by Neimark Labs, 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 1992-11-06.
- Submission: K923776
- Applicant / Sponsor: Neimark Labs, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1992-11-06
Classification & Regulation
This clearance is catalogued under FDA product code HXY and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.