Clearance Summary
TYPE 316L COTTER WIRE received FDA 510(k) clearance under submission number K864375, sponsored by Winn Hirsch & Assoc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1987-05-20.
- Submission: K864375
- Applicant / Sponsor: Winn Hirsch & Assoc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 1987-05-20
Classification & Regulation
This clearance is catalogued under FDA product code LRN and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.