FDA.reportPublic FDA data

Veritas rTSA Instrumentation

Primary DI
00840097535975
Brand
Veritas rTSA Instrumentation
Company
Restor3d, Inc.
Model
5500-H42U1
Device description
Trial - Humeral Poly - Standard, Neutral lateralization, 42 mm sphere
Published
2026-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243643000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243643000restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D2025-05-19PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840097535975PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097535975008400975359758400975359750840097535975

GMDN Terms#

Term, Definition table
TermDefinition
Reverse shoulder cup prosthesis trial, reusableA copy of a final reverse shoulder prosthesis cup designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is intended to connect to a reverse shoulder prosthesis/trial prosthesis body and articulates with a reverse shoulder prosthesis/trial prosthesis head; it is 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
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00840097532394Veritas rTSA Instrumentation5500-40012026-05-14
00840097532400Veritas rTSA Instrumentation5500-41112026-05-14
00840097532417Veritas rTSA Instrumentation5500-43012026-05-14
00840097532424Veritas rTSA Instrumentation5500-44012026-05-14
00840097533780Total Knee Instrumentation5201-10042026-05-14
00840097533797Total Knee Instrumentation5201-10052026-05-14
00840097533803Total Knee Instrumentation5201-10062026-05-14
00840097533810Veritas rTSA Instrumentation5500-42012026-05-14
00840097534169Ossera™ AFX Instrumentation5740-98112026-05-14
00840097534176Ossera™ AFX Instrumentation5740-98122026-05-14
00840097534299Veritas rTSA1501-3202-N2026-05-14
00840097535968Veritas rTSA Instrumentation5500-45012026-05-14
00840097535999Veritas rTSA Instrumentation5500-H42U32026-05-14
00840097536385Veritas rTSA Instrumentation4520-10042026-05-14
00840097536408Veritas rTSA1501-3204-N2026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033390115698SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121712SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121736SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121743SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121804SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121828SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121835SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121859SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121873SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121880SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121897SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121910SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121958SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390108065SMR STEMLESSLIMACORPORATE SPAPHX2022-03-17
08033390134392SMR ShoulderLIMACORPORATE SPAPHX2021-11-27
07613327507096REUNIONStryker GmbHPHX2021-11-02
07613327354317REUNIONStryker GmbHPHX2021-04-27
07613327354348REUNIONStryker GmbHPHX2021-04-27
07613327354362REUNIONStryker GmbHPHX2021-04-27
07613327354393REUNIONStryker GmbHPHX2021-04-27
07613327354409REUNIONStryker GmbHPHX2021-04-27
07613327354782REUNIONStryker GmbHPHX2021-04-27
07613327354812REUNIONStryker GmbHPHX2021-04-27
07613327354829REUNIONStryker GmbHPHX2021-04-27
07613327354836REUNIONStryker GmbHPHX2021-04-27
07613327354881REUNIONStryker GmbHPHX2021-04-27
07613327354911REUNIONStryker GmbHPHX2021-04-27
07613327354928REUNIONStryker GmbHPHX2021-04-27
07613327354959REUNIONStryker GmbHPHX2021-04-27
07613327354966REUNIONStryker GmbHPHX2021-04-27