FDA.reportPublic FDA data

Velora Acetabular System Instrumentation

Primary DI
00840097535654
Brand
Velora Acetabular System Instrumentation
Company
Restor3d, Inc.
Model
6903-K036
Device description
Velora Single Use Liner Trial, GRP K (72), 36mm, LAT
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
00840097535654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097535654008400975356548400975356540840097535654

GMDN Terms#

Term, Definition table
TermDefinition
Acetabulum prosthesis trial, prefabricated, single-useA 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.

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
00840097536675Velora Acetabular System Instrumentation5900-91092026-08-19
00840097519395Ossera AFX1741-36002026-08-14
00840097519401Ossera AFX1741-38002026-08-14
00840097519418Ossera AFX1741-40002026-08-14
00840097519425Ossera AFX1741-42002026-08-14
00840097534800Ossera AFX1741-44002026-08-14
00840097534817Ossera AFX1742-36342026-08-14
00840097534824Ossera AFX1742-36382026-08-14
00840097534831Ossera AFX1742-38382026-08-14
00840097534848Ossera AFX1742-38422026-08-14
00840097534855Ossera AFX1742-40402026-08-14
00840097534862Ossera AFX1742-40442026-08-14
00840097534879Ossera AFX1742-42422026-08-14
00840097534886Ossera AFX1742-42462026-08-14
00840097534893Ossera AFX1742-44442026-08-14
00840097534909Ossera AFX1742-44482026-08-14
00840097513768Ossera™ AFX1741-4600-N2025-05-20
00840097517193Ossera™ AFX1741-3400-N2025-05-20
00840097517209Ossera™ AFX1741-3600-N2025-05-20
00840097517216Ossera™ AFX1741-3800-N2025-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097536675Velora Acetabular System InstrumentationRestor3d, Inc.LPH2026-08-19
00192629031999LineageMicroport Orthopedics Inc.LPH2026-08-18
00192629080515MICROPORTMicroport Orthopedics Inc.LPH2026-08-18
00192629176553MICROPORTMicroport Orthopedics Inc.LPH2026-08-18
00192629031951MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00192629031968LineageMicroport Orthopedics Inc.LPH2026-08-17
00192629031975LineageMicroport Orthopedics Inc.LPH2026-08-17
00192629031982LineageMicroport Orthopedics Inc.LPH2026-08-17
00192629163584MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00192629176515MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00192629176522MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00192629176539MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00192629176546MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00193982895006TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895013TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895020TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895037TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895044TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895075TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895082TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895099TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895105TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895112TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895136TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895143TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895150TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895167TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895174TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14