Clearance Summary
SIMPLANT DR. JAMES received FDA 510(k) clearance under submission number K053592, sponsored by Materialise NV. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2006-02-08.
- Submission: K053592
- Applicant / Sponsor: Materialise NV
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2006-02-08
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.