Clearance Summary
PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549) received FDA 510(k) clearance under submission number K091725, sponsored by U&I Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2009-11-09.
- Submission: K091725
- Applicant / Sponsor: U&I Corp.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2009-11-09
Classification & Regulation
This clearance is catalogued under FDA product code MNH and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.