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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K203588
Device Name ELEOS™ Limb Salvage System
Applicant
Onkos Surgical
77 E. Halsey Rd.
Parsippany,  NJ  07054
Applicant Contact Matthew Vernak
Correspondent
Onkos Surgical
77 E. Halsey Rd.
Parsippany,  NJ  07054
Correspondent Contact Matthew Vernak
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
JWH   KRO   LPH   LZO  
Date Received12/08/2020
Decision Date 02/05/2021
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
Recalls CDRH Recalls
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