Clearance Summary
TYPE 316L STAINLESS STEEL WIRE received FDA 510(k) clearance under submission number K880309, 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 1988-02-29.
- Submission: K880309
- Applicant / Sponsor: Winn Hirsch & Assoc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3010
- Decision date: 1988-02-29
Classification & Regulation
This clearance is catalogued under FDA product code JDQ and 21 CFR 888.3010, within the Orthopedic review panel as a Class II device.