Clearance Summary
ACE MOS SAW AND THE ACE MOS SPINE SAW received FDA 510(k) clearance under submission number K862504, sponsored by Buckman Co., 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 1986-08-07.
- Submission: K862504
- Applicant / Sponsor: Buckman Co., Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.4580
- Decision date: 1986-08-07
Classification & Regulation
This clearance is catalogued under FDA product code JDX and 21 CFR 888.4580, within the Orthopedic review panel as a Class II device.