FDA.reportPublic FDA data

R3

Primary DI
00885556307397
Brand
R3
Company
Smith & Nephew, Inc.
Model
71332376
Catalog number
71332376
Device description
R3 ANTEVERTED XLPE LINER 28MM INNER DIAMETER X OUTER DIAMETER 54MM +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
00885556307397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556307397008855563073978855563073970885556307397

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
03596010627308JOURNEY71422341714223412015-08-30
03596010627315JOURNEY71422342714223422015-08-30
03596010627339JOURNEY71422344714223442015-08-30
03596010627346JOURNEY71422345714223452015-08-30
03596010627360JOURNEY71422347714223472015-08-30
03596010627377JOURNEY71422351714223512015-08-30
03596010627384JOURNEY71422352714223522015-08-30
03596010627391JOURNEY71422353714223532015-08-30
03596010627407JOURNEY71422354714223542015-08-30
03596010627421JOURNEY71422356714223562015-08-30
03596010627438JOURNEY71422357714223572015-08-30
03596010629777JOURNEY71422346714223462015-08-30
03596010627322JOURNEY71422343714223432015-08-30
03596010627414JOURNEY71422355714223552015-08-30
03596010627445JOURNEY71422361714223612015-08-30
03596010627452JOURNEY71422362714223622015-08-30
03596010627469JOURNEY71422363714223632015-08-30
03596010627476JOURNEY71422364714223642015-08-30
03596010627483JOURNEY71422365714223652015-08-30
03596010627490JOURNEY71422366714223662015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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07613153071327RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071334RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071341RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071358RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071365RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071372RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071389RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071396RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071402RestorationHowmedica Osteonics Corp.MBL2015-09-24
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