510(k) K151651

NuVasive X-CORE Mini Cervical Expandable VBR System by Nu Vasive, Incorporated — Product Code PLR

K151651 is an FDA 510(k) premarket notification submitted by Nu Vasive, Incorporated for the device "NuVasive X-CORE Mini Cervical Expandable VBR System". The FDA issued a decision of Substantially Equivalent on September 25, 2015. The device falls under product code PLR (Spinal Vertebral Body Replacement Device - Cervical), 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
September 25, 2015
Date Received
June 18, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinal Vertebral Body Replacement Device - Cervical
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Vertebral body replacement in the cervical spine.