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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K201379
Device Name Artemis Proximal Femoral Nail System
Applicant
Glw, Inc.
300 Sylvan Ave.
Englewood Cliff,  NJ  07632
Applicant Contact Arundhati Radhakrishnan
Correspondent
Lincé Consulting, LLC
111 Deerwood Rd., Suite 200
San Ramon,  CA  95483
Correspondent Contact Nancy Lincé
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
HWC  
Date Received05/26/2020
Decision Date 02/19/2021
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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