Clearance Summary
SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION received FDA 510(k) clearance under submission number K132365, sponsored by Accel Spine. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2013-08-20.
- Submission: K132365
- Applicant / Sponsor: Accel Spine
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2013-08-20
Classification & Regulation
This clearance is catalogued under FDA product code MNI and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.