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
10603295079941AML EXCEL2001-42-0002001420002018-09-24
10603295080008AML EXCEL2001-47-0002001470002018-09-24
10603295080015AML EXCEL2001-48-0002001480002018-09-24
10603295080022AML EXCEL2001-49-0002001490002018-09-24
10603295080145NA2001-80-5012001805012018-09-24
10603295080770NA2002-25-0002002250002018-09-24
10603295080787NA2002-27-0002002270002018-09-24
10603295080794NA2002-31-0002002310002018-09-24
10603295082057TRI-LOCK2012-03-0052012030052018-09-24
10603295082064TRI-LOCK2012-03-0102012030102018-09-24
10603295082071TRI-LOCK2012-03-0202012030202018-09-24
10603295082088TRI-LOCK2012-03-0302012030302018-09-24
10603295082095TRI-LOCK2012-03-0402012030402018-09-24
10603295082101TRI-LOCK2012-03-0502012030502018-09-24
10603295082118TRI-LOCK2012-03-0602012030602018-09-24
10603295082125TRI-LOCK2012-03-0702012030702018-09-24
10603295082132TRI-LOCK2012-03-0802012030802018-09-24
10603295082149TRI-LOCK2012-03-0902012030902018-09-24
10603295082156TRI-LOCK2012-03-1002012031002018-09-24
10603295082163TRI-LOCK2012-03-1102012031102018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033390266567PRIMALIMACORPORATE SPAPAO2024-07-27
08033390266574PRIMALIMACORPORATE SPAPAO2024-07-27
08033390267472PRIMALIMACORPORATE SPAPAO2024-07-27
08033390267496PRIMALIMACORPORATE SPAPAO2024-07-27
08033390267502PRIMALIMACORPORATE SPAPAO2024-07-27
08033390268486PRIMALIMACORPORATE SPAPAO2024-07-27
08033390268493PRIMALIMACORPORATE SPAPAO2024-07-27
08033390260312PRIMA TT GlenoidLIMACORPORATE SPAPAO2024-03-12
08033390260367PRIMA TT GlenoidLIMACORPORATE SPAPAO2024-03-12
08033390266536PRIMALIMACORPORATE SPAPAO2024-03-12
08033390266581PRIMALIMACORPORATE SPAPAO2024-03-12
08033390268462PRIMALIMACORPORATE SPAPAO2024-03-12
08033390268509PRIMALIMACORPORATE SPAPAO2024-03-12
08033390268516PRIMALIMACORPORATE SPAPAO2024-03-12
08033390268523PRIMALIMACORPORATE SPAPAO2024-03-12
08033390268554PRIMALIMACORPORATE SPAPAO2024-03-12
08033390268578PRIMALIMACORPORATE SPAPAO2024-03-12
08033390268622PRIMALIMACORPORATE SPAPAO2024-03-12
08033390268639PRIMALIMACORPORATE SPAPAO2024-03-12
08033390268646PRIMALIMACORPORATE SPAPAO2024-03-12
08033390268653PRIMALIMACORPORATE SPAPAO2024-03-12
08033390268660PRIMALIMACORPORATE SPAPAO2024-03-12
08033390268677PRIMALIMACORPORATE SPAPAO2024-03-12
08033390266550PRIMALIMACORPORATE SPAPAO2024-02-07
08033390266857PRIMALIMACORPORATE SPAPAO2024-02-07
08033390266864PRIMALIMACORPORATE SPAPAO2024-02-07
08033390266871PRIMALIMACORPORATE SPAPAO2024-02-07
08033390266888PRIMALIMACORPORATE SPAPAO2024-02-07
08033390266895PRIMALIMACORPORATE SPAPAO2024-02-07
08033390266901PRIMALIMACORPORATE SPAPAO2024-02-07