Clearance Summary
MCCONNELL REAMER GUIDE received FDA 510(k) clearance under submission number K885100, sponsored by Mcconnell Orthopedic. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1989-01-13.
- Submission: K885100
- Applicant / Sponsor: Mcconnell Orthopedic
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1989-01-13
Classification & Regulation
This clearance is catalogued under FDA product code HTO and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.