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FDA 510(k) Application Details - K112097
Device Classification Name
System, Facet Screw Spinal Device
More FDA Info for this Device
510(K) Number
K112097
Device Name
System, Facet Screw Spinal Device
Applicant
EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE, FL 32653 US
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Contact
VLADISLAVA ZAITSEVA
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Regulation Number
000.0000
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Classification Product Code
MRW
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More FDA Info for this Product Code
Date Received
07/22/2011
Decision Date
11/21/2011
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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