FDA.reportPublic FDA data

GLOBAL UNITE

Primary DI
10603295444749
Brand
GLOBAL UNITE
Company
DEPUY (IRELAND)
Model
1407-20-101
Catalog number
140720101
Device description
GLOBAL UNITE PLATFORM SHOULDER SYSTEM REVERSE FX EPI CENTER POROCOAT
Published
2018-03-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
PHXshoulder prosthesis, reverse configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170748000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170748000GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018-01-11PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295444749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329544474910603295444749

GMDN Terms#

Term, Definition table
TermDefinition
Reverse shoulder prosthesis bodyA sterile component of a reverse shoulder prosthesis that consists of a metallic piece [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)], which may be coated [e.g., with hydroxyapatite (HA)], intended to form a connection between a humeral stem prosthesis and a reverse shoulder prosthesis cup.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
989365556
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295170655S-ROM52-15035215032015-09-24
10603295170662S-ROM52-15045215042015-09-24
10603295170679S-ROM52-15055215052015-09-24
10603295170686S-ROM52-15255215252015-09-24
10603295170693S-ROM52-15305215302015-09-24
10603295170709S-ROM52-15355215352015-09-24
10603295170716S-ROM52-15405215402015-09-24
10603295170723S-ROM52-15455215452015-09-24
10603295170730S-ROM52-15525215522015-09-24
10603295170747S-ROM52-15535215532015-09-24
10603295170754S-ROM52-15545215542015-09-24
10603295170761S-ROM52-15555215552015-09-24
10603295175155S-ROM55-02355502352015-09-24
10603295175162S-ROM55-02955502952015-09-24
10603295022435LCS COMPLETE1294-09-3401294093402015-03-24
10603295022442LCS COMPLETE1294-09-3501294093502015-03-24
10603295022459LCS COMPLETE1294-09-3601294093602015-03-24
10603295022466LCS COMPLETE1294-09-3701294093702015-03-24
10603295022756LCS COMPLETE1294-09-8101294098102015-03-24
10603295022763LCS COMPLETE1294-09-8201294098202015-03-24

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 INDUSTRIEHSD2026-08-03
03661489725463JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEPHX2026-08-03
03661489725463JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEKWS2026-08-03
00840097513119Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00840097513126Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00840097513133Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00840097516004Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00840097516011Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00811596031886Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031886Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031893Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031893Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031909Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031909Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17