Clearance Summary
VULCAN TAC PROBES, MODEL 911XXX received FDA 510(k) clearance under submission number K003198, sponsored by Oratec Interventions, 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 2001-08-29.
- Submission: K003198
- Applicant / Sponsor: Oratec Interventions, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 2001-08-29
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.