FDA.reportPublic FDA data

Velora Acetabular System Instrumentation

Primary DI
00840097535616
Brand
Velora Acetabular System Instrumentation
Company
Restor3d, Inc.
Model
6903-H036
Device description
Velora Single Use Liner Trial, GRP H (60-62), 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
00840097535616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097535616008400975356168400975356160840097535616

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
00840097503011restor3d Osteotomy Wedge1100-002-221409072021-09-01
00840097503028restor3d Osteotomy Wedge1100-002-221410072021-09-01
00840097503073restor3d Osteotomy Wedge1100-002-221405072021-09-01
00840097503080restor3d Osteotomy Wedge1100-002-221406072021-09-01
00840097503097restor3d Osteotomy Wedge1100-002-221407072021-09-01
00840097503103restor3d Osteotomy Wedge1100-002-221408072021-09-01
00840097504674restor3d Osteotomy Wedge1100-002-221405102022-08-18
00840097504681restor3d Osteotomy Wedge1100-002-221406132022-08-18
00840097504698restor3d Osteotomy Wedge1100-002-221407152022-08-18
00840097504704restor3d Osteotomy Wedge1100-002-221408182022-08-18
00840097504711restor3d Osteotomy Wedge1100-002-221410232022-08-18
00840097504728restor3d Osteotomy Wedge1100-002-221412282022-08-18
00840097504735restor3d Osteotomy Wedge1100-002-181205132022-08-18
00840097504742restor3d Osteotomy Wedge1100-002-181206162022-08-18
00840097504759restor3d Osteotomy Wedge1100-002-181207192022-08-18
00840097504766restor3d Osteotomy Wedge1100-002-181208222022-08-18
00840097504773restor3d Osteotomy Wedge1100-002-181210282022-08-18
00840097504780restor3d Osteotomy Wedge1100-002-181212342022-08-18
00840097503110restor3d Disposable Instrument, Wedge Trial6100-NSP-A04052021-11-15
00840097503127restor3d Disposable Instrument, Wedge Trial6100-NSP-A05062021-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024713512G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713529G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713536G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713543G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713550G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713567G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713574G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713581G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713598G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713604G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713611G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713628G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713635G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713642G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713659G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713666G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713673G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713680G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713697G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713703G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713734G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713741G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713758G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713765G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713772G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713789G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713796G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713802G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713819G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713826G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03