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510(k) K131724

PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE by Pioneer Surgical Technology, Inc. — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 2013
Date Received
June 12, 2013
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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