FDA.reportPublic FDA data

INHANCE

Primary DI
10603295538264
Brand
INHANCE
Company
DEPUY (IRELAND)
Model
5200-00-032
Catalog number
520000032
Device description
INHANCE SHOULDER SYSTEM STEMLESS SMALL DIAMETER 32mm CEMENTLESS
Published
2021-11-17
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
PAOprosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented
PKCProsthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PAOProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, CementedOrthopedic2
PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-ConstrainedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295538264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329553826410603295538264

GMDN Terms#

Term, Definition table
TermDefinition
Humeral metaphyseal anchorA sterile implantable device designed to provide fixation within the humeral metaphysis for the attachment of a dedicated humeral head prosthesis. It is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is in the form of a small framework to achieve a mechanical interlock with bone without the use of bone cement.

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
10603295033141S-ROM1365-16-5001365165002015-09-24
10603295033158S-ROM1365-17-5001365175002015-09-24
10603295033165S-ROM1365-18-5001365185002015-09-24
10603295033738S-ROM1365-41-5001365415002015-09-24
10603295033752S-ROM1365-42-5001365425002015-09-24
10603295033776S-ROM1365-43-5001365435002015-09-24
10603295033790S-ROM1365-44-5001365445002015-09-24
10603295033851S-ROM1365-45-5001365455002015-09-24
10603295033875S-ROM1365-47-5001365475002015-09-24
10603295034056S-ROM1365-61-5001365615002015-09-24
10603295034094S-ROM1365-62-5001365625002015-09-24
10603295034131S-ROM1365-63-5001365635002015-09-24
10603295034179S-ROM1365-64-5001365645002015-09-24
10603295034216S-ROM1365-65-5001365655002015-09-24
10603295034230S-ROM1365-66-5001365665002015-09-24
10603295170778S-ROM52-20225220222015-09-24
10603295079941AML EXCEL2001-42-0002001420002018-09-24
10603295080008AML EXCEL2001-47-0002001470002018-09-24
10603295080015AML EXCEL2001-48-0002001480002018-09-24
10603295080022AML EXCEL2001-49-0002001490002018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862657244EquinoxeExactech, Inc.PAO2026-07-07
10885862657251EquinoxeExactech, Inc.PAO2026-07-07
10885862657268EquinoxeExactech, Inc.PAO2026-07-07
10885862657275EquinoxeExactech, Inc.PAO2026-07-07
10885862657282EquinoxeExactech, Inc.PAO2026-07-07
10885862657299EquinoxeExactech, Inc.PAO2026-07-07
10885862657305EquinoxeExactech, Inc.PAO2026-07-07
10885862657312EquinoxeExactech, Inc.PAO2026-07-07
10885862657329EquinoxeExactech, Inc.PAO2026-07-07
10885862657336EquinoxeExactech, Inc.PAO2026-07-07
10885862657343EquinoxeExactech, Inc.PAO2026-07-07
10885862657350EquinoxeExactech, Inc.PAO2026-07-07
10885862657367EquinoxeExactech, Inc.PAO2026-07-07
10885862657374EquinoxeExactech, Inc.PAO2026-07-07
10885862657381EquinoxeExactech, Inc.PAO2026-07-07
10885862657398EquinoxeExactech, Inc.PAO2026-07-07
10885862657442EquinoxeExactech, Inc.PAO2026-07-07
10885862657459EquinoxeExactech, Inc.PAO2026-07-07
10885862657466EquinoxeExactech, Inc.PAO2026-07-07
10885862657473EquinoxeExactech, Inc.PAO2026-07-07
03701037307007Humelock II Cementless Shoulder SystemFX SOLUTIONSPKC2026-06-25
03701037319109ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPKC2026-06-25
03701037319116ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPKC2026-06-25
03701037319123ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPKC2026-06-25
03701037319130ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPKC2026-06-25
03701037320426EasyTech AnatomicalFX SOLUTIONSPKC2025-03-03
08033390266567PRIMALIMACORPORATE SPAPAO2024-07-27
08033390266574PRIMALIMACORPORATE SPAPAO2024-07-27
08033390267472PRIMALIMACORPORATE SPAPAO2024-07-27
08033390267496PRIMALIMACORPORATE SPAPAO2024-07-27