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510(k) K190418

NuVasive® VersaTie® System by Nu Vasive, Incorporated — Product Code OWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2019
Date Received
February 21, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Fixation Cerclage, Sublaminar
Device Class
Class II
Regulation Number
888.3010
Review Panel
OR
Submission Type

Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.

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