Clearance Summary
NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM received FDA 510(k) clearance under submission number K141253, sponsored by New Era Orthopaedics, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2015-01-09.
- Submission: K141253
- Applicant / Sponsor: New Era Orthopaedics, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2015-01-09
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.