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510(k) K093776

INDUS ANTERIOR CERVICAL PLATE SYSTEM by Spinefrontier, Inc. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2010
Date Received
December 8, 2009
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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