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510(k) K203253

NuVasive ACP System by Nu Vasive, Incorporated — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2020
Date Received
November 4, 2020
Clearance Type
Special
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

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