Clearance Summary
ENNOVATE Spinal System received FDA 510(k) clearance under submission number K210963, sponsored by Aesculap Implant Systems, 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 2021-07-19.
- Submission: K210963
- Applicant / Sponsor: Aesculap Implant Systems, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2021-07-19
Classification & Regulation
This clearance is catalogued under FDA product code NKB and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.