FDA.reportPublic FDA data

R3

Primary DI
00885556308196
Brand
R3
Company
Smith & Nephew, Inc.
Model
71332405
Catalog number
71332405
Device description
R3 ANTEVERTED XLPE LINER 36MM INNER DIAMETER X OUTER DIAMETER 60MM +4
Published
2018-12-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MBLProsthesis, hip, semi-constrained, uncemented, metal/polymer, porous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182535000
K211176000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182535000R3 Anteverted LinersSmith & Nephew, Inc.2018-11-19MBL
K211176000Smith & Nephew Hip SystemsSmith & Nephew, Inc.2022-07-01LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556308196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556308196008855563081968855563081960885556308196

GMDN Terms#

Term, Definition table
TermDefinition
Non-constrained polyethylene acetabular linerA sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.

Sterilization Methods#

Method table
Method
Ethylene Oxide

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
03596010469182GENESIS II71421012714210122015-08-30
03596010469212GENESIS II71421015714210152015-08-30
03596010469229GENESIS II71421016714210162015-08-30
03596010469236GENESIS II71421017714210172015-08-30
03596010469267GENESIS II71421112714211122015-08-30
03596010469274GENESIS II71421113714211132015-08-30
03596010469281GENESIS II71421114714211142015-08-30
03596010469298GENESIS II71421115714211152015-08-30
03596010469304GENESIS II71421116714211162015-08-30
03596010469328GENESIS II71421118714211182015-08-30
03596010531018JOURNEY74024629740246292015-08-29
03596010531025JOURNEY74024632740246322015-08-29
03596010554468JOURNEY74024623740246232015-08-29
03596010554475JOURNEY74024626740246262015-08-29
03596010554512JOURNEY74024826740248262015-08-29
03596010554529JOURNEY74024829740248292015-08-29
03596010554536JOURNEY74024832740248322015-08-29
03596010000675OXINIUM71343603713436032015-08-30
03596010469199GENESIS II71421013714210132015-08-30
03596010469205GENESIS II71421014714210142015-08-30

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Primary DI, Brand, Company table
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07613153071358RestorationHowmedica Osteonics Corp.MBL2015-09-24
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07613153071396RestorationHowmedica Osteonics Corp.MBL2015-09-24
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07613153071419RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071426RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071433RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071440RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071518RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071587RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071594RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071600RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071617RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071631RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071648RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071655RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153072867TridentHowmedica Osteonics Corp.MBL2015-09-24
07613153072874TridentHowmedica Osteonics Corp.MBL2015-09-24
07613153072881TridentHowmedica Osteonics Corp.MBL2015-09-24
07613153072898TridentHowmedica Osteonics Corp.MBL2015-09-24
07613153072904TridentHowmedica Osteonics Corp.MBL2015-09-24