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FDA 510(k) Application Details - K112684
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
More FDA Info for this Device
510(K) Number
K112684
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
QUALGENIX
1 JACK'S HILL ROAD
UNIT 3E
OXFORD, CT 06478 US
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Contact
RICHARD DESLAURIERS
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
09/15/2011
Decision Date
05/01/2012
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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