Clearance Summary
PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS received FDA 510(k) clearance under submission number K932853, sponsored by Applied Osteo Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1994-02-22.
- Submission: K932853
- Applicant / Sponsor: Applied Osteo Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4680
- Decision date: 1994-02-22
Classification & Regulation
This clearance is catalogued under FDA product code JEL and 21 CFR 874.4680, within the Ear, Nose, Throat review panel as a Class II device.