510(k) K212446

NuVasive Anterior Cervical Plate Systems by Nu Vasive, Incorporated — Product Code KWQ

K212446 is an FDA 510(k) premarket notification submitted by Nu Vasive, Incorporated for the device "NuVasive Anterior Cervical Plate Systems". The FDA issued a decision of Substantially Equivalent on November 3, 2021. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Nu Vasive, Incorporated has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2021
Date Received
August 5, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type