Clearance Summary
IMSE P-TLIF received FDA 510(k) clearance under submission number K130506, sponsored by Institute of Musculoskeletal Science & Education. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2013-05-13.
- Submission: K130506
- Applicant / Sponsor: Institute of Musculoskeletal Science & Education
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2013-05-13
Classification & Regulation
This clearance is catalogued under FDA product code MAX and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.