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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 Intervertebral Body
510(k) Number K171439
Device Name EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System
Applicant
Medos International SARL
Chemin-Blanc 38
Lelocle,  CH 2400
Applicant Contact Catherine Kilshaw
Correspondent
Depuy Synthes Spine
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Sheree Geller
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received05/16/2017
Decision Date 07/20/2017
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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