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FDA 510(k) Application Details - K082914
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
More FDA Info for this Device
510(K) Number
K082914
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
SYNTHES SPINE
1302 WRIGHTS LANE EAST
WEST CHESTER, PA 19380 US
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Contact
JASON LIPMAN
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
09/30/2008
Decision Date
12/11/2008
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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