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510(k) K151651

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

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.

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