FDA.reportPublic FDA data

JOURNEY

Primary DI
03596010581891
Brand
JOURNEY
Company
Smith & Nephew, Inc.
Model
71422216
Catalog number
71422216
Device description
JOURNEY DEUCE FEMORAL OXZR SIZE 6 RIGHT
Published
2015-09-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NPJPROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052265000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052265000SMITH & NEPHEW COMPETITOR DUO KNEE FEMORALSmith & Nephew, Inc.2005-12-27NPJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010581891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010581891035960105818913596010581891

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556925171REAL INTELLIGENCEROB100021FROB100021F2026-07-30
00885556925188REAL INTELLIGENCEROB100022FROB100022F2026-07-30
00885556925195REAL INTELLIGENCEROB10024FROB10024F2026-07-30
00885556925201REAL INTELLIGENCEROB10025FROB10025F2026-07-30
00885556925218REAL INTELLIGENCEROB10027FROB10027F2026-07-30
00885556925225REAL INTELLIGENCEROB10003FROB10003F2026-07-30
00885556925232REAL INTELLIGENCEROB10013FROB10013F2026-07-30
00885556925249REAL INTELLIGENCEROB10015FROB10015F2026-07-30
00885556757277REAL INTELLIGENCEROB10010ROB100102020-07-02
00885556757307REAL INTELLIGENCEROB10011ROB100112020-07-02
00885556757314REAL INTELLIGENCEROB10012ROB100122020-07-02
00885556909393NA52856B52856B2025-09-24
00885556909317NA52858-0152858-012025-05-08
00885556909331NA52858-0252858-022025-05-08
00885556909348NA55085550852025-05-08
00885556909362NA52781-1052781-102025-05-08
00885556909386NA52876B52876B2025-05-08
00885556909423NA52855-4052855-402025-05-08
00885556909430NA52855-6552855-652025-05-08
00885556909447NA52781A52781A2025-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327127423INSTRUMENTHowmedica Osteonics Corp.NPJ2017-11-24
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07613327127492INSTRUMENTHowmedica Osteonics Corp.NPJ2017-11-24
07613327127515INSTRUMENTHowmedica Osteonics Corp.NPJ2017-11-24
07613327127522INSTRUMENTHowmedica Osteonics Corp.NPJ2017-11-24
07613327127560INSTRUMENTHowmedica Osteonics Corp.NPJ2017-11-24
07613327127607INSTRUMENTHowmedica Osteonics Corp.NPJ2017-11-24
07613327049305AvonHowmedica Osteonics Corp.NPJ2017-06-19
07613154557431INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051094INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051100INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051117INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051124INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051131INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051148INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051155INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051162INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051179INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051193INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051209INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051216INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051223INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051230INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051247INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327127546INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327127553INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327127577INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24