Clearance Summary
MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE received FDA 510(k) clearance under submission number K990120, sponsored by Depuy Ace Medical Co.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1999-02-01.
- Submission: K990120
- Applicant / Sponsor: Depuy Ace Medical Co.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3020
- Decision date: 1999-02-01
Classification & Regulation
This clearance is catalogued under FDA product code HSB and 21 CFR 888.3020, within the Orthopedic review panel as a Class II device.