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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
510(k) Number K211677
Device Name ELEOS Limb Salvage System
Applicant
Onkos Surgical
77 E. Halsey Rd.
Parsippany,  NJ  07054
Applicant Contact Matthew (Matt) Vernak
Correspondent
Onkos Surgical
77 E. Halsey Rd.
Parsippany,  NJ  07054
Correspondent Contact Matthew (Matt) Vernak
Regulation Number888.3510
Classification Product Code
KRO  
Subsequent Product Codes
JDI   JWH   LPH   LZO  
Date Received06/01/2021
Decision Date 07/28/2021
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
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