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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K161259
Device Name KLS Martin Cannulated Headless Screws
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 GARY MOORE
Regulation Number888.3040
Classification Product Code
HWC  
Date Received05/04/2016
Decision Date 12/19/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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