Clearance Summary
CustomizedBone Service received FDA 510(k) clearance under submission number K171507, sponsored by Fin-Ceramica Faenza S.P.A.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2017-09-01.
- Submission: K171507
- Applicant / Sponsor: Fin-Ceramica Faenza S.P.A.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5330
- Decision date: 2017-09-01
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.