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510(k) K061002

MAXIMA ANTERIOR CERVICAL PLATE SYSTEM by U&I Corp. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2006
Date Received
April 11, 2006
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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