Clearance Summary
VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM received FDA 510(k) clearance under submission number K964402, sponsored by V. Mueller Neuro/Spine. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1997-01-23.
- Submission: K964402
- Applicant / Sponsor: V. Mueller Neuro/Spine
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4800
- Decision date: 1997-01-23
Classification & Regulation
This clearance is catalogued under FDA product code GZT and 21 CFR 882.4800, within the Neurology review panel as a Class II device.