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FDA 510(k) Application Details - K080026
Device Classification Name
Orthosis, Spinal Pedicle Fixation
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510(K) Number
K080026
Device Name
Orthosis, Spinal Pedicle Fixation
Applicant
PIONEER SURGICAL TECHNOLOGY
375 RIVER PARK CIRCLE
MARQUETTE, MI 49855-0627 US
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Contact
JONATHAN M GILBERT
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Regulation Number
888.3070
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Classification Product Code
MNI
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More FDA Info for this Product Code
Date Received
01/04/2008
Decision Date
01/28/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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