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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 K213199
Device Name Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System
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 Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received09/29/2021
Decision Date 01/11/2022
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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