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FDA 510(k) Application Details - K090408
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
More FDA Info for this Device
510(K) Number
K090408
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
PARADIGM SPINE, LLC
1331 H STREET NW
12TH FLOOR
WASHINGTON, DC 20005 US
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Contact
ADAM HERDER
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
02/18/2009
Decision Date
03/20/2009
Decision
SESU - SE - WITH LIMITATIONS
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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