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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 K253066
Device Name ELEOS™ with NanoCept® Technology Limb Salvage System
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 Arley Perez
Classification Product Code
QZZ  
Subsequent Product Codes
JDI   JWH   KRO   LPH   LZO  
Date Received09/22/2025
Decision Date 06/08/2026
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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