Velora Acetabular System Instrumentation

Basic Information

• Brand Name: Velora Acetabular System Instrumentation
• Primary DI: 00840097535388
• Version / Model: 6902-D036
• Company Name: Restor3d, Inc.
• Labeler DUNS: 080819836
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-15
• Public Version: 1
• Public Version Date: 2025-12-23
• Public Version Status: New
• Public Device Record Key: bc8649ac-d6d9-4db2-9502-f2e7dbb48d48

Device Description

Velora Single Use Liner Trial, GRP D (50), 36mm, FCL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	888.3358	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62303	Acetabulum prosthesis trial, prefabricated, single-use	A copy of a final acetabular cup prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer materials and may be designed in the form of cages, shells or inserts. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840097535388	GS1

Premarket Submissions

Submission Number	Supplement Number
K252067	000