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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K254306
Device Name Aevumed FENIX Suture Anchor
Applicant
Aevumed, Inc.
109 Great Valley Pkwy.
Malvern,  PA  19355
Applicant Contact Saif Khalil
Correspondent
Aevumed, Inc.
109 Great Valley Pkwy.
Malvern,  PA  19355
Correspondent Contact Saif Khalil
Regulation Number888.3040
Classification Product Code
MBI  
Date Received12/31/2025
Decision Date 03/04/2026
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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