FDA.reportPublic FDA data

SIGMA

Primary DI
10603295155508
Brand
SIGMA
Company
DEPUY INTERNATIONAL LTD
Model
2960-09-400
Catalog number
296009400
Device description
SIGMA RP-F NON POROUS FEMUR TRIAL SIZE 4N RIGHT
Published
2018-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295155508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329515550810603295155508

GMDN Terms#

Term, Definition table
TermDefinition
Knee femur prosthesis trial, reusableA copy of a final femur prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee tibia trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes femoral articulation trials, femoral spacer trials, femoral wedge/augment trials, anterior stop trials, stem adaptor trials, and stem trials. This is a reusable device.

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
896498813
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
10603295155492SIGMA2960-08-4002960084002018-09-24
10603295210320NA8555-06-0008555060002018-09-24
10603295119708AML234-52-10002345210002018-09-24
10603295224341NA9505-01-0329505010322018-09-24
10603295224792LCS9505-01-1199505011192018-09-24
10603295226581PATHWAY9505-01-5229505015222018-09-24
10603295226598NA9505-01-5239505015232018-09-24
10603295226604NA9505-01-5249505015242018-09-24
10603295241065CHARNLEY9620-73-0009620730002018-09-24
10603295026853NA1299-01-0291299010292016-06-30
10603295026952NA1299-01-0581299010582018-09-24
10603295147657C-STEM2580-00-0342580000342018-09-24
10603295147664C-STEM2580-00-0352580000352018-09-24
10603295147671C-STEM2580-00-0362580000362018-09-24
10603295147688C-STEM2580-00-0372580000372018-09-24
10603295147695C-STEM2580-00-0382580000382018-09-24
10603295147701C-STEM2580000392580000392018-09-24
10603295147718C-STEM2580000402580000402018-09-24
10603295147725C-STEM2580000412580000412018-09-24
10603295147732C-STEM2580000452580000452018-09-24

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
00860009784925Flap Marking TemplateMirrorme3d, LLCHWT2023-03-17
00860009784918TemplateMirrorme3d, LLCHWT2023-02-16
00885556841532XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841549XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841556XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
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00885556841587XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841594XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841600XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841655XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841662XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841679XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841686XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841693XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841709XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841716XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841723XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841730XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02