Veritas Reverse Total Shoulder

Primary DI
00840097513126
Brand
Veritas Reverse Total Shoulder
Company
Restor3d, Inc.
Model
6500-9002
Device description
Patient-Specific Baseplate Trial
Published
2026-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
PHXShoulder Prosthesis, Reverse Configuration
QHEShoulder Arthroplasty Implantation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2
QHEShoulder Arthroplasty Implantation SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253992000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253992000Veritas Reverse Total Shoulder SystemRestor3D2026-05-07PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840097513126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097513126008400975131268400975131260840097513126

GMDN Terms#

Term, Definition table
TermDefinition
Shoulder reverse/standard adaptor prosthesis trialA copy of a final shoulder reverse/standard adaptor prosthesis designed to be used before revision implant surgery to validate the appropriate size of the permanent prosthesis required by the patient, and to ensure its proper orientation and positioning. It is double male taper disc typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080819836
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
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
00811596032036Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032050Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032067Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032074Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032081Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032098Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032104Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032111Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032128Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032135Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032142Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032159Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032166Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032173Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032180Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032197Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
03661489725463JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEPHX2026-08-03
00840097513119Veritas Reverse Total ShoulderRestor3d, Inc.QHE2026-07-24
00840097513119Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00840097513133Veritas Reverse Total ShoulderRestor3d, Inc.QHE2026-07-24
00840097513133Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00840097516004Veritas Reverse Total ShoulderRestor3d, Inc.QHE2026-07-24
00840097516004Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00840097516011Veritas Reverse Total ShoulderRestor3d, Inc.QHE2026-07-24
00840097516011Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00811596031886Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031893Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031909Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031916Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031923Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17