FDA.reportPublic FDA data

INHANCE

Primary DI
10603295539049
Brand
INHANCE
Company
DEPUY (IRELAND)
Model
6200-20-028
Catalog number
620020028
Device description
INHANCE SHOULDER SYSTEM HUMERAL BLAZER X-SMALL diameter 28mm
Published
2021-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTZINSTRUMENT, CUTTING, ORTHOPEDIC
MBFPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTZInstrument, Cutting, OrthopedicGeneral, Plastic Surgery1
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295539049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329553904910603295539049

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
989365556
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.MBF2026-05-28
07649988948701SPIRECUTSPIRECUT SAHTZ2026-05-04
07649988948718SPIRECUTSPIRECUT SAHTZ2026-05-04
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