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FDA 510(k) Application Details - K113625
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
More FDA Info for this Device
510(K) Number
K113625
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
PARADIGM SPINE, LLC
1331 H STREET NW
12TH FLOOR
WASHINGTON, DC 20005 US
Other 510(k) Applications for this Company
Contact
MICHELLE MCDONOUGH
Other 510(k) Applications for this Contact
Regulation Number
888.3070
More FDA Info for this Regulation Number
Classification Product Code
NKB
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More FDA Info for this Product Code
Date Received
12/08/2011
Decision Date
01/10/2012
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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