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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, Porous Uncemented
510(k) Number K223348
Device Name My3D® Personalized Pelvic Reconstruction
Applicant
Onkos Surgical, Inc.
77 E. Halsey Rd.
Parsippany,  NJ  07054
Applicant Contact Matthew Vernak
Correspondent
Onkos Surgical, Inc.
77 E. Halsey Rd.
Parsippany,  NJ  07054
Correspondent Contact Matthew Vernak
Regulation Number888.3358
Classification Product Code
LPH  
Date Received11/02/2022
Decision Date 01/30/2023
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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