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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K260156
Device Name TruVision Single-Use 1.9mm Arthroscopy System
Applicant
Nexus CMF, LLC
2825 E. Cottonwood Pkwy.
Suite 330
Salt Lake City,  UT  84121
Applicant Contact Wittwer Tiffini
Correspondent
Mededge Consulting
2825 E. Cottonwood Pkwy.
Suite 330
Salt Lake City,  UT  84121
Correspondent Contact Billi-Jo Pfalzgraf
Regulation Number888.1100
Classification Product Code
HRX  
Date Received01/20/2026
Decision Date 10/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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