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510(k) K112757

PIONEER POSTERIOR CERVICO THORACIC SYSTEM by Pioneer Surgical Technology, Inc. — Product Code KWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2012
Date Received
September 22, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type

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