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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, fixation, bone
510(k) Number K190670
Device Name ORTHOLOC™ 2 Lapidus with Rotation System
Applicant
Wright Medical Technology, Inc.
1023 Cherry Road
Memphis,  TN  38117
Applicant Contact Alayne Melancon
Correspondent
Wright Medical Technology, Inc.
1023 Cherry Road
Memphis,  TN  38117
Correspondent Contact Alayne Melancon
Regulation Number888.3030
Classification Product Code
HRS  
Date Received03/15/2019
Decision Date 05/14/2019
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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