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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 K202777
Device Name VeriFixx™ Small Bone Implant
Applicant
Armis Biopharma, Inc.
2950 E. Harmony Rd. Suite 252
Fort Collins,  CO  80528
Applicant Contact Franklin Okumu
Correspondent
Pharmatech Associates, Inc.
22320 Foothill Blvd. Suite 330
Hayward,  CA  94541
Correspondent Contact Lynn C. Hansen
Regulation Number888.3040
Classification Product Code
HTY  
Date Received09/22/2020
Decision Date 11/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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