Clearance Summary
NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty received FDA 510(k) clearance under submission number K203714, sponsored by Nu Vasive, Incorporated. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2021-12-23.
- Submission: K203714
- Applicant / Sponsor: Nu Vasive, Incorporated
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2021-12-23
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.