Clearance Summary
SMOOTH OR THREADED METALLIC BONE FASTENER received FDA 510(k) clearance under submission number K131640, sponsored by Biomedical Ent., 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 2013-10-16.
- Submission: K131640
- Applicant / Sponsor: Biomedical Ent., Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2013-10-16
Classification & Regulation
This clearance is catalogued under FDA product code HTY and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.