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FDA 510(k) Application Details - K062196
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
More FDA Info for this Device
510(K) Number
K062196
Device Name
Orthosis, Spondyloisthesis Spinal Fixation
Applicant
DEPUY SPINE, INC.
325 PARAMOUNT DR.
RAYNHAM, MA 02767 US
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Contact
MARY GRAY
Other 510(k) Applications for this Contact
Regulation Number
888.3070
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Classification Product Code
MNH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/01/2006
Decision Date
09/11/2006
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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