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FDA 510(k) Application Details - K081883
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
More FDA Info for this Device
510(K) Number
K081883
Device Name
Orthosis, Spondyloisthesis Spinal Fixation
Applicant
US SPINE
13540 GUILD AVE
APPLE VALLEY, MN 55124 US
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Contact
RICHARD JANSEN
Other 510(k) Applications for this Contact
Regulation Number
888.3070
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Classification Product Code
MNH
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More FDA Info for this Product Code
Date Received
07/02/2008
Decision Date
09/24/2008
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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