FDA.reportPublic FDA data

DELTA XTEND

Primary DI
10603295116103
Brand
DELTA XTEND
Company
DEPUY (IRELAND)
Model
2307-73-003
Catalog number
230773003
Device description
DELTA Xtend SUPERIOR LATERAL CUTTING GUIDE
Published
2018-06-19
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
HWTTEMPLATE
PHXshoulder prosthesis, reverse configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTZInstrument, Cutting, OrthopedicGeneral, Plastic Surgery1
HWTTemplateOrthopedic1
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170748000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170748000GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018-01-11PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295116103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329511610310603295116103

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
10603295168324SMARTSET3092-02030920202015-09-24
10603295168331SMARTSET3092-04030920402015-09-24
10603295168614NA3312-04033120402015-09-24
10603295168621NA3322-02033220202015-09-24
10603295168638NA3332-04033320402015-09-24
10603295005438GLOBAL AP1130-02-0001130020002015-09-24
10603295218289S-ROM87-34358734352015-09-24
10603295218470S-ROM87-35568735562015-09-24
10603295218487S-ROM87-35578735572015-09-24
10603295218951S-ROM87-59878759872015-09-24
10603295519935VELYS4515-70-2264515702262021-05-26
10603295519430VELYS4515-70-1024515701022021-05-13
10603295519492VELYS4515-70-1014515701012021-05-13
10603295519515VELYS4515-70-1004515701002021-05-13
10603295519379VELYS4515-70-1074515701072021-05-07
10603295519461VELYS4515-70-1054515701052021-05-07
10603295519478VELYS4515-70-1064515701062021-05-07
10603295519485VELYS4515-70-1094515701092021-05-07
10603295170655S-ROM52-15035215032015-09-24
10603295170662S-ROM52-15045215042015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295553588ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-08-26
10603295553595ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-08-26
10603295553601ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-08-26
10603295553618ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-08-26
10705034579900N/AMedos International SàrlHWT2026-08-26
10705034579917N/AMedos International SàrlHWT2026-08-26
10705034579924N/AMedos International SàrlHWT2026-08-26
00811596032524F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032531F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032548F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032555F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032562F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032579F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032586F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032593F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032609F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032616F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032623F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032630F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032647F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032654F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032661F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032678F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032685F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032982F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00889024711464Comp Mini Humeral Tray Trial Stem AdapterZimmer, Inc.HWT2026-08-25
00889024713277Universal Uni Knee TensorZimmer, Inc.HWT2026-08-25
00889024713284Right Uni Knee TensorZimmer, Inc.HWT2026-08-25
00889024713291Left Uni Knee TensorZimmer, Inc.HWT2026-08-25
05404028001028SurgiCase PlannerMaterialise NVPHX2025-08-28