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FDA 510(k) Application Details - K121850
Device Classification Name
System, Facet Screw Spinal Device
More FDA Info for this Device
510(K) Number
K121850
Device Name
System, Facet Screw Spinal Device
Applicant
CHOICE SPINE, LP
400 Erin Dr
KNOXVILLE, TN 37919 US
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Contact
KIM FINCH
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MRW
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More FDA Info for this Product Code
Date Received
06/25/2012
Decision Date
09/20/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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