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FDA 510(k) Application Details - K112748
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
More FDA Info for this Device
510(K) Number
K112748
Device Name
Appliance, Fixation, Spinal Intervertebral Body
Applicant
SPINAL USA LLC
2050 Executive Dr
Pearl, MS 39208 US
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Contact
FRANKIE CUMMINS
Other 510(k) Applications for this Contact
Regulation Number
888.3060
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Classification Product Code
KWQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/21/2011
Decision Date
07/11/2012
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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