Clearance Summary
NBD HEAD SCREW received FDA 510(k) clearance under submission number K050377, sponsored by New Business Development, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2005-04-07.
- Submission: K050377
- Applicant / Sponsor: New Business Development, LLC
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2005-04-07
Classification & Regulation
This clearance is catalogued under FDA product code HAW and 21 CFR 882.4560, within the Neurology review panel as a Class II device.