Clearance Summary
MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT received FDA 510(k) clearance under submission number K110684, sponsored by Vanduzen Dba Medcad. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2011-06-24.
- Submission: K110684
- Applicant / Sponsor: Vanduzen Dba Medcad
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5330
- Decision date: 2011-06-24
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.