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FDA 510(k) Application Details - K073562
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
More FDA Info for this Device
510(K) Number
K073562
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
DEPUY SPINE, INC.
325 PARAMOUNT DR.
RAYNHAM, MA 02767 US
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Contact
CHRISTOPHER KLACZYK
Other 510(k) Applications for this Contact
Regulation Number
888.3070
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Classification Product Code
NKB
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More FDA Info for this Product Code
Date Received
12/19/2007
Decision Date
05/15/2008
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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