FDA.reportPublic FDA data

Velora Acetabular System

Primary DI
00840097532905
Brand
Velora Acetabular System
Company
Restor3d, Inc.
Model
1902-J066
Device description
Velora, 3DP Acetabular Cup, Multi Hole, 66mm
Published
2025-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252067000Velora Acetabular SystemRestor3D, Inc.2025-12-05LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840097532905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097532905008400975329058400975329050840097532905

GMDN Terms#

Term, Definition table
TermDefinition
Acetabular shellAn implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080819836
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840097536668Veritas rTSA Instrumentation5500-32022026-06-25
00840097535678Veritas rTSA3500-142U12026-06-03
00840097535692Veritas rTSA3500-142C12026-06-03
00840097535715Veritas rTSA3500-142U32026-06-03
00840097535739Veritas rTSA3500-142C32026-06-03
00840097535753Veritas rTSA3500-342U12026-06-03
00840097535777Veritas rTSA3500-342C12026-06-03
00840097535791Veritas rTSA3500-342U32026-06-03
00840097535814Veritas rTSA3500-342C32026-06-03
00840097535838Veritas rTSA3500-542U12026-06-03
00840097535852Veritas rTSA3500-542C12026-06-03
00840097535876Veritas rTSA3500-542U32026-06-03
00840097535890Veritas rTSA3500-542C32026-06-03
00840097534978Veritas rTSA1501-42012026-06-02
00840097534985Veritas rTSA1501-42042026-06-02
00840097513218Veritas rTSA1500-10152026-05-14
00840097513225Veritas rTSA1500-10302026-05-14
00840097513232Veritas rTSA1500-10352026-05-14
00840097513249Veritas rTSA1500-10452026-05-14
00840097532356Veritas rTSA Instrumentation6500-20472026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04026575448678MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448685MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448760MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448777MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448784MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448791MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448807MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448814MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448821MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448838MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448845MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448852MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448869MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448876MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448883MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448890MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
00810068850079Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850086Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850093Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850109Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850116Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850123Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850130Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850147Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850154Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850185Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850192Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850208Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850215Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850222Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26