Clearance Summary
DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI received FDA 510(k) clearance under submission number K974245, sponsored by Depuy Ace Medical Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1998-05-22.
- Submission: K974245
- Applicant / Sponsor: Depuy Ace Medical Co.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 1998-05-22
Classification & Regulation
This clearance is catalogued under FDA product code LXT and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.