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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 K252067
Device Name Velora Acetabular System
Applicant
Restor3D, Inc.
4001 Nc-54 Hwy.
Suite 3160
Durham,  NC  27709
Applicant Contact Knox Pittman
Correspondent
Restor3D, Inc.
4001 Nc-54 Hwy.
Suite 3160
Durham,  NC  27709
Correspondent Contact Knox Pittman
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
LZO   MEH   OQG  
Date Received07/01/2025
Decision Date 12/05/2025
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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