FDA.reportPublic FDA data

GLOBAL ADVANTAGE

Primary DI
10603295005360
Brand
GLOBAL ADVANTAGE
Company
DEPUY ORTHOPAEDICS, INC.
Model
1128-65-080
Catalog number
112865080
Device description
GLOBAL ADVANTAGE CTA HEAD SIZE 56mm x 23mm
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000575000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000575000GLOBAL ADVANTAGE EXTENDED HUMERAL HEADDePuy Orthopaedics, Inc.2000-03-10KWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295005360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329500536010603295005360

GMDN Terms#

Term, Definition table
TermDefinition
Stem-fixed metallic humeral head prosthesisAn implantable artificial substitute for a diseased or injured humeral head. It is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and designed to be attached to a humeral stem prosthesis and to articulate with the natural glenoid fossa, a glenoid fossa prosthesis, or a humeral head bipolar component as part of a shoulder replacement.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080506581
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295553588ATTUNE2999-67-0282999670282026-08-26
10603295553595ATTUNE2999-67-0292999670292026-08-26
10603295553601ATTUNE2999-67-0302999670302026-08-26
10603295553618ATTUNE2999-67-0312999670312026-08-26
10603295552680ATTUNE2999670062999670062026-05-29
10603295555001ATTUNE2999-67-0492999670492026-05-29
10603295555018ATTUNE2999-67-0502999670502026-05-29
10603295555025ATTUNE2999-67-0512999670512026-05-29
10603295555032ATTUNE2999-67-0522999670522026-05-29
10603295555049ATTUNE2999-67-0532999670532026-05-29
10603295555056ATTUNE2999-67-0542999670542026-05-29
10603295555544ATTUNE2999-67-0842999670842026-05-29
10603295555582ATTUNE2999-67-0852999670852026-05-29
10603295015154DURALOC1220-28-1481220281482015-09-24
10603295015161DURALOC1220-28-1501220281502015-09-24
10603295015178DURALOC1220-28-1521220281522015-09-24
10603295015185DURALOC1220-28-1541220281542015-09-24
10603295015192DURALOC1220-28-1561220281562015-09-24
10603295015208DURALOC1220-28-1581220281582015-09-24
10603295015215DURALOC1220-28-1601220281602015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097533919Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533926Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533933Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533940Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533957Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533964Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533971Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533988Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533995Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097534008Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097534015Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097534022Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
B1132N2GI200050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI200100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI206000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI208000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI220050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI220100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI226000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI228000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI240050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI240100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI246000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI248000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI270050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI270100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI276000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI278000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
03661489725463JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2026-08-03
03661489725463JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEKWS2026-08-03