FDA.reportPublic FDA data

R3

Primary DI
00885556309940
Brand
R3
Company
Smith & Nephew, Inc.
Model
71332471
Catalog number
71332471
Device description
R3 ANTEVERTED LINER TRIAL 36MM INNER DIAMETER X OUTER DIAMETER 52MM +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
00885556309940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556309940008855563099408855563099400885556309940

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
03596010619952NA72201597722015972015-08-29
03596010619969NA72201598722015982015-08-29
00885556572351NA72201597S72201597S2017-06-15
00885556572368NA72201598S72201598S2017-06-15
00885556830543PyroCarbon Modular Radial HeadTRL-310-01TRL-310-012026-09-24
00885556830550PyroCarbon Modular Radial HeadTRL-310-02TRL-310-022026-09-24
00885556830567PyroCarbon Modular Radial HeadTRL-310-03TRL-310-032026-09-24
00885556830574PyroCarbon Modular Radial HeadTRL-310-04TRL-310-042026-09-24
00885556839690Total Foot System 2CSA-800-06CSA-800-062026-09-24
00885556839706Total Foot System 2CSA-800-07CSA-800-072026-09-24
00885556854778Cadence Total Ankle SystemCSA-1020-0014CSA-1020-00142026-09-24
00885556859636Titan Modular Shoulder SystemCSA092009CSA0920092026-09-24
00885556859643Titan Modular Shoulder SystemCSA092010CSA0920102026-09-24
00885556859650Titan Modular Shoulder SystemCSA092011CSA0920112026-09-24
00885556859698Titan Modular Shoulder SystemCSA-0920-15CSA-0920-152026-09-24
00885556859704Titan Modular Shoulder SystemCSA-0920-16CSA-0920-162026-09-24
00885556859711Titan Modular Shoulder SystemCSA-0920-17CSA-0920-172026-09-24
00885556859728Titan Modular Shoulder SystemCSA-0920-18CSA-0920-182026-09-24
00885556859735Titan Modular Shoulder SystemCSA-0920-19CSA-0920-192026-09-24
00885556859742Titan Modular Shoulder SystemCSA-0920-20CSA-0920-202026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04546540273260OrthinoxHowmedica Osteonics Corp.MBL2015-09-24
04546540273291OrthinoxHowmedica Osteonics Corp.MBL2015-09-24
04546540273314OrthinoxHowmedica Osteonics Corp.MBL2015-09-24
04546540273345OrthinoxHowmedica Osteonics Corp.MBL2015-09-24
04546540273369OrthinoxHowmedica Osteonics Corp.MBL2015-09-24
04546540273390OrthinoxHowmedica Osteonics Corp.MBL2015-09-24
04546540402158OrthinoxHowmedica Osteonics Corp.MBL2015-09-24
04546540402165OrthinoxHowmedica Osteonics Corp.MBL2015-09-24
04546540402172OrthinoxHowmedica Osteonics Corp.MBL2015-09-24
04546540402189OrthinoxHowmedica Osteonics Corp.MBL2015-09-24
04546540432001TridentHowmedica Osteonics Corp.MBL2015-09-24
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