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FDA 510(k) Application Details - K121671
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
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510(K) Number
K121671
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
ZIMMER SPINE, INC.
7375 Bush Lake Rd
Minneapolis, MN 55439 US
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Contact
DAVID PADGETT
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Regulation Number
888.3070
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Classification Product Code
NKB
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Date Received
06/06/2012
Decision Date
07/18/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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