Clearance Summary
SPINE-TECH LAPAROSCOPIC INSTRUMENTATION SYSTEM received FDA 510(k) clearance under submission number K940913, sponsored by Spine-Tech, 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 1994-10-04.
- Submission: K940913
- Applicant / Sponsor: Spine-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 1994-10-04
Classification & Regulation
This clearance is catalogued under FDA product code HRX and 21 CFR 888.1100, within the Orthopedic review panel as a Class II device.