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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Limb And Joint Salvage Device With Coating For Bacteria Reduction
510(k) Number K252920
Device Name ELEOS™ Limb Salvage System with NanoCept® Technology
Applicant
Onkos Surgical, Inc.
77 E. Halsey Rd.
Parsippany,  NJ  07054
Applicant Contact Arley Perez
Correspondent
Onkos Surgical, Inc.
77 E. Halsey Rd.
Parsippany,  NJ  07054
Correspondent Contact Elizabeth Rose
Classification Product Code
QZZ  
Subsequent Product Code
KRO  
Date Received09/12/2025
Decision Date 10/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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