Clearance Summary
PATIENT CONTOURED MESH-PEEK (PCM-P) received FDA 510(k) clearance under submission number K072707, sponsored by KLS-Martin L.P.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2007-12-19.
- Submission: K072707
- Applicant / Sponsor: KLS-Martin L.P.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5330
- Decision date: 2007-12-19
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.