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FDA 510(k) Application Details - K153631
Device Classification Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
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510(K) Number
K153631
Device Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
Applicant
Zimmer Spine, Inc
7375 Bush Lake Road
Minneapolis, MN 55439 US
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Contact
Ted Kuhn
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
NKG
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More FDA Info for this Product Code
Date Received
12/18/2015
Decision Date
02/16/2016
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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