Clearance Summary
SPINAL WRENCH received FDA 510(k) clearance under submission number K813067, sponsored by Twin City Surgical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1981-11-24.
- Submission: K813067
- Applicant / Sponsor: Twin City Surgical, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1981-11-24
Classification & Regulation
This clearance is catalogued under FDA product code HXC and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.