Clearance Summary
HARMONY PORT SYSTEM, MODEL 1907 SERIES received FDA 510(k) clearance under submission number K050706, sponsored by Spinal Concepts, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2005-04-15.
- Submission: K050706
- Applicant / Sponsor: Spinal Concepts, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4800
- Decision date: 2005-04-15
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.