FDA.reportPublic FDA data

GLOBAL AP

Primary DI
10603295005544
Brand
GLOBAL AP
Company
DEPUY ORTHOPAEDICS, INC.
Model
1130-12-200
Catalog number
113012200
Device description
GLOBAL AP POROCOAT STANDARD STEM SIZE 12 137mm
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
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
MBFPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011047000
K063652000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011047000GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOATDePuy Orthopaedics, Inc.2001-06-28MBF
K063652000GLOBAL AP POROUS COATED HUMERAL STEMDePuy Orthopaedics, Inc.2007-02-01MBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295005544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329500554410603295005544

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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00811596031718EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031725EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031732EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031749EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031657EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031664EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031671EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031688EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00889024707047Signature ONE Software PackageOrthosoft IncKWS2026-07-10
00889024707047Signature ONE Software PackageOrthosoft IncMBF2026-07-10
10885862657244EquinoxeExactech, Inc.KWS2026-07-07
10885862657251EquinoxeExactech, Inc.KWS2026-07-07
10885862657268EquinoxeExactech, Inc.KWS2026-07-07
10885862657275EquinoxeExactech, Inc.KWS2026-07-07
10885862657282EquinoxeExactech, Inc.KWS2026-07-07
10885862657299EquinoxeExactech, Inc.KWS2026-07-07
10885862657305EquinoxeExactech, Inc.KWS2026-07-07
10885862657312EquinoxeExactech, Inc.KWS2026-07-07
10885862657329EquinoxeExactech, Inc.KWS2026-07-07
10885862657336EquinoxeExactech, Inc.KWS2026-07-07
10885862657343EquinoxeExactech, Inc.KWS2026-07-07
10885862657350EquinoxeExactech, Inc.KWS2026-07-07
10885862657367EquinoxeExactech, Inc.KWS2026-07-07
10885862657374EquinoxeExactech, Inc.KWS2026-07-07
10885862657381EquinoxeExactech, Inc.KWS2026-07-07
10885862657398EquinoxeExactech, Inc.KWS2026-07-07