Clearance Summary
KLEIN WIRE TIGHTENER/BIONIC WIRE received FDA 510(k) clearance under submission number K833726, sponsored by Bionic Instrument Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1983-12-22.
- Submission: K833726
- Applicant / Sponsor: Bionic Instrument Corp.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1983-12-22
Classification & Regulation
This clearance is catalogued under FDA product code HXS and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.