Clearance Summary
RAYLOR(TM) MALLET received FDA 510(k) clearance under submission number K864422, sponsored by Cedar Surgical, 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 1986-11-24.
- Submission: K864422
- Applicant / Sponsor: Cedar Surgical, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1986-11-24
Classification & Regulation
This clearance is catalogued under FDA product code HWA and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.