Velora Acetabular System Instrumentation

GUDID 00840097535128

Velora Single Use Liner Trial, GRP G (56-58), 40mm, STD

Restor3d, Inc.

Acetabulum prosthesis trial, prefabricated, single-use

• Primary Device ID: 00840097535128
• NIH Device Record Key: 0d936045-928f-49fe-a50b-7e8d33dda8b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Velora Acetabular System Instrumentation
• Version Model Number: 6900-G040
• Company DUNS: 080819836
• Company Name: Restor3d, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840097535128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252067

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-23
• Device Publish Date: 2025-12-15

On-Brand Devices [Velora Acetabular System Instrumentation]

• 00840097536378: Reamer, Acetabular, 72mm Full
• 00840097536361: Reamer, Acetabular, 71mm Full
• 00840097536354: Reamer, Acetabular, 70mm Full
• 00840097536347: Reamer, Acetabular, 69mm Full
• 00840097536330: Reamer, Acetabular, 68mm Full
• 00840097536323: Reamer, Acetabular, 67mm Full
• 00840097536316: Reamer, Acetabular, 66mm Full
• 00840097536309: Reamer, Acetabular, 65mm Full
• 00840097536293: Reamer, Acetabular, 64mm Full
• 00840097536286: Reamer, Acetabular, 63mm Full
• 00840097536279: Reamer, Acetabular, 62mm Full
• 00840097536262: Reamer, Acetabular, 61mm Full
• 00840097536255: Reamer, Acetabular, 60mm Full
• 00840097536248: Reamer, Acetabular, 59mm Full
• 00840097536231: Reamer, Acetabular, 58mm Full
• 00840097536224: Reamer, Acetabular, 57mm Full
• 00840097536217: Reamer, Acetabular, 56mm Full
• 00840097536200: Reamer, Acetabular, 55mm Full
• 00840097536194: Reamer, Acetabular, 54mm Full
• 00840097536187: Reamer, Acetabular, 53mm Full
• 00840097536170: Reamer, Acetabular, 52mm Full
• 00840097536163: Reamer, Acetabular, 51mm Full
• 00840097536156: Reamer, Acetabular, 50mm Full
• 00840097536149: Reamer, Acetabular, 49mm Full
• 00840097536132: Reamer, Acetabular, 48mm Full
• 00840097536125: Reamer, Acetabular, 47mm Full
• 00840097536118: Reamer, Acetabular, 46mm Full
• 00840097536101: Reamer, Acetabular, 45mm Full
• 00840097536095: Reamer, Acetabular, 44mm Full
• 00840097536088: Reamer, Acetabular, 43mm Full
• 00840097536071: Reamer, Acetabular, 42mm Full
• 00840097536064: Reamer, Acetabular, 41mm Full
• 00840097536057: Reamer, Acetabular, 40mm Full
• 00840097536040: Reamer, Acetabular, 39mm Full
• 00840097536033: Reamer, Acetabular, 38mm Full
• 00840097536026: Reamer, Acetabular, 37mm Full
• 00840097536019: Reamer, Acetabular, 36mm Full
• 00840097535661: Velora Single Use Liner Trial, GRP K (72), 40mm, LAT
• 00840097535654: Velora Single Use Liner Trial, GRP K (72), 36mm, LAT
• 00840097535647: Velora Single Use Liner Trial, GRP J (64-70), 40mm, LAT
• 00840097535630: Velora Single Use Liner Trial, GRP J (64-70), 36mm, LAT
• 00840097535623: Velora Single Use Liner Trial, GRP H (60-62), 40mm, LAT
• 00840097535616: Velora Single Use Liner Trial, GRP H (60-62), 36mm, LAT
• 00840097535609: Velora Single Use Liner Trial, GRP G (56-58), 40mm, LAT
• 00840097535593: Velora Single Use Liner Trial, GRP G (56-58), 36mm, LAT
• 00840097535586: Velora Single Use Liner Trial, GRP F (54), 40mm, LAT
• 00840097535579: Velora Single Use Liner Trial, GRP F (54), 36mm, LAT
• 00840097535562: Velora Single Use Liner Trial, GRP E (52), 40mm, LAT
• 00840097535555: Velora Single Use Liner Trial, GRP E (52), 36mm, LAT
• 00840097535548: Velora Single Use Liner Trial, GRP D (50), 36mm, LAT