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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pin, fixation, smooth
510(k) Number K201715
Device Name Smart Toe II, X Fuse
Applicant
Stryker GmbH
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact Jemin Dedania
Correspondent
Stryker GmbH
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact Jemin Dedania
Regulation Number888.3040
Classification Product Code
HTY  
Date Received06/23/2020
Decision Date 08/05/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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