Clearance Summary
Intra-Lock Bone Fixation System received FDA 510(k) clearance under submission number K171831, sponsored by Intra-Lock International, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2017-10-26.
- Submission: K171831
- Applicant / Sponsor: Intra-Lock International, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4880
- Decision date: 2017-10-26
Classification & Regulation
This clearance is catalogued under FDA product code DZL and 21 CFR 872.4880, within the Dental review panel as a Class II device.