FDA.reportPublic FDA data

R3

Primary DI
00885556309643
Brand
R3
Company
Smith & Nephew, Inc.
Model
71332437
Catalog number
71332437
Device description
R3 ANTEVERTED LINER TRIAL 32MM INNER DIAMETER X OUTER DIAMETER 48MM +4
Published
2018-12-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182535000R3 Anteverted LinersSmith & Nephew, Inc.2018-11-19MBL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556309643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556309643008855563096438855563096430885556309643

GMDN Terms#

Term, Definition table
TermDefinition
Acetabulum prosthesis trial, reusableA copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Sterilization required before use
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
Primary DIBrandCompanyProduct codePublished
07613153071273RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071280RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071297RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071310RestorationHowmedica Osteonics Corp.MBL2015-09-24
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