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510(k) K150666

uNion Cervical Plate System by Ulrich Medical USA — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2015
Date Received
March 16, 2015
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

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