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510(k) K051525

ARX SPINAL SYSTEM by Amedica Corp. — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2006
Date Received
June 8, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinal Vertebral Body Replacement Device
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

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