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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, facet screw spinal device
510(k) Number K112097
Device Name GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
Original Applicant
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville,  FL  32653
Original Contact vladislava zaitseva
Classification Product Code
MRW  
Date Received07/22/2011
Decision Date 11/21/2011
Decision substantially equivalent (SESE)
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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