FDA.reportPublic FDA data

GLOBAL ADVANTAGE

Primary DI
10603295007104
Brand
GLOBAL ADVANTAGE
Company
DEPUY ORTHOPAEDICS, INC.
Model
1137-08-050
Catalog number
113708050
Device description
GLOBAL ADVANTAGE POROCOAT STANDARD STEM SIZE 8 133mm
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
MBFPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011047000GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOATDePuy Orthopaedics, Inc.2001-06-28MBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295007104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329500710410603295007104

GMDN Terms#

Term, Definition table
TermDefinition
Coated shoulder humeral stem prosthesisA sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

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
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
10603295015222DURALOC1220-28-1621220281622015-09-24
10603295015239DURALOC1220-28-1641220281642015-09-24
10603295015246DURALOC1220-28-1661220281662015-09-24
10603295015536DURALOC1220-32-1521220321522015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.MBF2026-05-28
08033390002233SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390002240SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390002257SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390050029SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390050036SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390115667SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390115711SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121484SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121507SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121514SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121521SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121545SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121569SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121583SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121590SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121613SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121637SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121644SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121668SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121682SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121699SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121927SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121972SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121989SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390122009SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390122023SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390122030SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390122047SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390153119SMR ShoulderLIMACORPORATE SPAMBF2024-07-26