Clearance Summary
DURAGEN SECURE DURAL REGNERATION MATRIX received FDA 510(k) clearance under submission number K120600, sponsored by Integra Life Sciences. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2012-06-15.
- Submission: K120600
- Applicant / Sponsor: Integra Life Sciences
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5910
- Decision date: 2012-06-15
Classification & Regulation
This clearance is catalogued under FDA product code GXQ and 21 CFR 882.5910, within the Neurology review panel as a Class II device.