FDA.reportPublic FDA data

R3

Primary DI
00885556712214
Brand
R3
Company
Smith & Nephew, Inc.
Model
XH000478-1
Catalog number
XH000478-1
Device description
R3 ANTEVERTED XLPE ACETABULAR LINER 36MM X 50MM
Published
2018-02-08
Public version status
Update
Distribution status
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
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
K102370000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102370000R3 XLPE ANTEVERTED LINERSSmith & Nephew, Inc.2011-01-19MBL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556712214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556712214008855567122148855567122140885556712214

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

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
00885556819845Uni-CP Compression Plate286322ND286322ND2023-11-07
00885556819852Uni-CP Compression Plate286324ND286324ND2023-11-07
00885556819869Uni-CP Compression Plate286326ND286326ND2023-11-07
00885556819876Uni-CP Compression Plate286328ND286328ND2023-11-07
00885556819883Uni-CP Compression Plate286330ND286330ND2023-11-07
00885556819890Uni-CP Compression Plate286332ND286332ND2023-11-07
00885556819906Uni-CP Compression Plate286334ND286334ND2023-11-07
00885556819357General Instruments219865ND219865ND2023-10-27
00885556846599Total Wrist Fusion186200ND186200ND2023-10-27
00885556910245UNI-CP Compression Plate186300ND186300ND2023-10-27
00885556819722Total Wrist Fusion286220ND286220ND2023-10-26
00885556819746Total Wrist Fusion286222ND286222ND2023-10-26
00885556819760Total Wrist Fusion286224ND286224ND2023-10-26
00885556819807UNI-CP Compression Plate286314ND286314ND2023-10-26
00885556819814UNI-CP Compression Plate286316ND286316ND2023-10-26
00885556819821UNI-CP Compression Plate286318ND286318ND2023-10-26
00885556819838UNI-CP Compression Plate286320ND286320ND2023-10-26
00885556847329UNI-CP Compression Plate219535ND219535ND2023-10-26
00885556819623Total Wrist Fusion286210ND286210ND2023-10-25
00885556819647SURFIXTotal Wrist Fusion286212ND286212ND2023-10-25

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