Clearance Summary
BioArchitects Patient Specific Cranial/Craniofacial Plate received FDA 510(k) clearance under submission number K151692, sponsored by Bioarchitects USA, 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 2015-11-20.
- Submission: K151692
- Applicant / Sponsor: Bioarchitects USA, LLC
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5330
- Decision date: 2015-11-20
Classification & Regulation
This clearance is catalogued under FDA product code GXN and 21 CFR 882.5330, within the Neurology review panel as a Class II device.