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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00889024702134Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702141Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702158Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702165Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702172Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702189Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702196Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702202Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024704916Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704923Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704930Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704947Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704954Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704961Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704978Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704985Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704992Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705005Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705012Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705029Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705036Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705043Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705050Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705067Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705074Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705081Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705098Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10