FDA 510(k), K203714, NuVasive Thoracolumbar Interbody Systems

Device Classification Name: Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number: K203714
Device Name: 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
Applicant: NuVasive, Incorporated
Regulation Number: 888.3080
Classification Product Code: MAX  
Subsequent Product Codes: MQV, OVD, PHM
Date Received: 12/21/2020
Decision Date: 12/23/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic

Total Pages: 3,045
Fully Redacted Pages: 1,915
Content Pages: 1,130