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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K210582
Device Name EasyClip® and EasyClip® Xpress
Applicant
Stryker GmbH
325 Corporate Dr.
Malwah,  NJ  07430
Applicant Contact Danielle Jannuzzi Madureira
Correspondent
Stryker GmbH
325 Corporate Dr.
Malwah,  NJ  07430
Correspondent Contact Danielle Jannuzzi Madureira
Regulation Number888.3030
Classification Product Code
JDR  
Date Received02/26/2021
Decision Date 06/10/2022
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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