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FDA 510(k) Application Details - K112727
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K112727
Device Name
Screw, Fixation, Bone
Applicant
MEDICAL FACETS
1669 FEDERAL AVENUE
GASTONIA, NC 2805 US
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Contact
GLENN A RUPP
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/20/2011
Decision Date
01/13/2012
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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