Clearance Summary
Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) received FDA 510(k) clearance under submission number K182711, sponsored by Kelyniam Global, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2019-05-21.
- Submission: K182711
- Applicant / Sponsor: Kelyniam Global, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5320
- Decision date: 2019-05-21
Classification & Regulation
This clearance is catalogued under FDA product code GWO and 21 CFR 882.5320, within the Neurology review panel as a Class II device.