Clearance Summary
ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System received FDA 510(k) clearance under submission number K210035, sponsored by Aegis Spine. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2021-02-16.
- Submission: K210035
- Applicant / Sponsor: Aegis Spine
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2021-02-16
Classification & Regulation
This clearance is catalogued under FDA product code OUR and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.