FDA.reportPublic FDA data

NovoKnee Total Knee System

Primary DI
00811382036989
Brand
NovoKnee Total Knee System
Company
Novosource, LLC
Model
3140-0000
Catalog number
3140-0000
Device description
NK Knee Case 3
Published
2018-02-27
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
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123339000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123339000TK1 TOTAL KNEE SYSTEMNovosource, Inc.2013-04-11JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811382036989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811382036989008113820369898113820369890811382036989

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
3045542167xx@xx.xx

Regulatory Flags#

DUNS number
081034828
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811382037658NovoHip Total Hip System1500-10161500-10162020-05-26
00811382037672NovoKnee Total Knee System3220-50243220-50242020-05-26
00811382037689NovoHip Total Hip System1345-36011345-36012020-11-03
00811382037696NovoHip Total Hip System1345-36021345-36022020-11-03
00811382037702NovoHip Total Hip System1345-36031345-36032020-11-03
00811382037719NovoHip Total Hip System1345-36041345-36042020-11-03
00811382037795NovoHip Total Hip System1345-28011345-28012021-04-20
00811382037801NovoHip Total Hip System1345-28021345-28022021-04-20
00811382037818NovoHip Total Hip System1345-28031345-28032021-04-20
00811382037825NovoHip Total Hip System1345-32011345-32012021-04-20
00811382037832NovoHip Total Hip System1345-32021345-32022021-04-20
00811382037849NovoHip Total Hip System1345-32031345-32032021-04-20
00811382037856NovoHip Total Hip System1345-32041345-32042021-04-20
00811382037726NovoKnee Total Knee System3120-51003120-51002024-07-19
00811382039287NovoHip Total Hip System1445-28051445-28052024-04-09
00811382039294NovoHip Total Hip System1445-32051445-32052024-04-09
00811382039300NovoHip Total Hip System1445-36051445-36052024-04-09
00811382039089NovoKnee Total Knee System3115-11013115-11012023-08-18
00811382039096NovoKnee Total Knee System3115-12013115-12012023-08-18
00811382039102NovoKnee Total Knee System3115-11023115-11022023-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800017269726EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269733EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269740EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269757EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269764EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269771EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269788EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017269795EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-05-21
08800017260853EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260860EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260877EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260884EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260891EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260907EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260914EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260921EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260938EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260945EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260952EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260969EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260976EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260983EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017260990EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017261003EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017261010EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017261027EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017261034EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017261041EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262178EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262185EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10