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FDA 510(k) Application Details - K092073
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
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510(K) Number
K092073
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
SIGNUS MEDICAL
188888 LAKE DRIVE EAST
CHANHASSEN, MN 55317 US
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Contact
THOMAS HOGHAUG
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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
07/08/2009
Decision Date
08/07/2009
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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