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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K133304
Device Name RXG DISTRACTION SYSTEM
Applicant
KLS-Martin L.P.
11201 Saint Johns Industrial Pkwy. S
Jacksonville,  FL  32246
Applicant Contact JENNIFER DAMATO
Correspondent
KLS-Martin L.P.
11201 Saint Johns Industrial Pkwy. S
Jacksonville,  FL  32246
Correspondent Contact JENNIFER DAMATO
Regulation Number872.4760
Classification Product Code
JEY  
Date Received10/28/2013
Decision Date 05/15/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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