FDA.reportPublic FDA data

OXINIUM

Primary DI
03596010652003
Brand
OXINIUM
Company
Smith & Nephew, Inc.
Model
71342344
Catalog number
71342344
Device description
44MM OXINIUM MODULAR FEMORAL HEAD
Published
2015-08-30
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
K093363000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093363000COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERSSmith & Nephew, Inc.2010-01-26MBL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010652003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010652003035960106520033596010652003

GMDN Terms#

Term, Definition table
TermDefinition
Metallic femoral head prosthesisAn implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA), or articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@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
03596010411020VERSABOND71271140712711402015-08-29
03596010494726VERSABOND71271340712713402015-08-29
03596010507372VERSABOND71271440712714402015-09-28
03596010033246NA1100281100282015-08-25
03596010038852NA1114301114302015-08-25
03596010038890NA1114341114342015-08-25
03596010041968BUCK1124281124282015-08-25
03596010384591MIXOR71270041712700412015-08-29
03596010384607MIXOR71270042712700422015-08-29
03596010384638MIXOR71270051712700512015-08-29
03596010384645MIXOR71270052712700522015-08-29
03596010437617RENOVATION71369045713690452015-08-30
03596010472175MIXOR71270060712700602015-08-29
03596010515018VORTEX71272001712720012015-08-29
03596010040077NA1118021118022015-08-25
00885556582213RALLY71271560712715602015-10-08
00885556582220RALLY71271570712715702015-10-08
00885556582237RALLY71271590712715902015-10-08
00885556582244RALLY71271580712715802015-10-08
00885556582275RALLY71271610712716102015-10-15

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Primary DI, Brand, Company table
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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
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07613153071518RestorationHowmedica Osteonics Corp.MBL2015-09-24