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510(k) K080815

TOSCA II ANTERIOR CERVICAL PLATE SYSTEM by Signus Medizintechnik GmbH — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2008
Date Received
March 24, 2008
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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