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FDA 510(k) Application Details - K051024
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
More FDA Info for this Device
510(K) Number
K051024
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
DEPUY SPINE, INC.
325 PARAMOUNT DR.
RAYNHAM, MA 02767 US
Other 510(k) Applications for this Company
Contact
SHARON STAROWICZ
Other 510(k) Applications for this Contact
Regulation Number
888.3070
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Classification Product Code
NKB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/22/2005
Decision Date
07/06/2005
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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