FDA.reportPublic FDA data

DELTA XTEND

Primary DI
10603295519010
Brand
DELTA XTEND
Company
DEPUY (IRELAND)
Model
2307-74-106
Catalog number
230774106
Device description
DELTA XTEND 145 RSA PROXIMAL REAM GUIDE 6mm
Published
2020-06-04
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
HWTTEMPLATE
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192855000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192855000DELTA XTEND(TM) Reverse Shoulder SystemDepuy(Ireland)2020-02-24PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295519010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329551901010603295519010

GMDN Terms#

Term, Definition table
TermDefinition
Total reverse shoulder prosthesisA sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the joint particularly in patients with chronic, longstanding rotator cuff muscle tears, arthritis, and/or humeral fractures unsuccessfully treated by previous surgery. The device reverses normal anatomy so that the head portion of the joint is attached to the scapula and the socket portion is attached to the humerus. It typically includes a humeral stem and glenosphere (head) with body and cup components. The device may include screws for implantation and may be implanted with or without bone cement.

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
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 NVKWS2025-08-28
03700434023831BlueprintTORNIERKWS2025-06-17
03700434023848BlueprintTORNIERKWS2025-06-17
00860009784925Flap Marking TemplateMirrorme3d, LLCHWT2023-03-17
08033390201858Smart SPACE SHOULDERLIMACORPORATE SPAKWS2023-02-18
08033390201872Smart SPACE SHOULDERLIMACORPORATE SPAKWS2023-02-18
08033390201896Smart SPACE SHOULDERLIMACORPORATE SPAKWS2023-02-18
08033390201919Smart SPACE SHOULDERLIMACORPORATE SPAKWS2023-02-18
08033390201933Smart SPACE SHOULDERLIMACORPORATE SPAKWS2023-02-18
08033390201957Smart SPACE SHOULDERLIMACORPORATE SPAKWS2023-02-18
08033390239509Smart SPACE SHOULDERLIMACORPORATE SPAKWS2023-02-18
08033390239516Smart SPACE SHOULDERLIMACORPORATE SPAKWS2023-02-18
00860009784918TemplateMirrorme3d, LLCHWT2023-02-16
00885556814963AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-10
00885556815083AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-10
00885556815090AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-10
00885556815113AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-10
00885556816455AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-10
00885556816462AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-10