Clearance Summary
RAYLOR BONE IMPACTORS received FDA 510(k) clearance under submission number K863415, sponsored by Cedar Surgical, 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 1986-09-24.
- Submission: K863415
- Applicant / Sponsor: Cedar Surgical, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.4535
- Decision date: 1986-09-24
Classification & Regulation
This clearance is catalogued under FDA product code HAO and 21 CFR 882.4535, within the Neurology review panel as a Class I device.