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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name appliance, fixation, spinal interlaminal
510(k) Number K121877
Device Name GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES
Original Applicant
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville,  FL  32653
Original Contact vladislava zaitseva
Regulation Number888.3050
Classification Product Code
KWP  
Date Received06/28/2012
Decision Date 02/12/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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