NovoKnee Total Knee System 3115-1101

GUDID 00811382039089

Size 1 CR Left Femoral Trial Stainless Steel

NOVOSOURCE, LLC

Knee femur prosthesis trial, reusable
Primary Device ID00811382039089
NIH Device Record Key55657ce2-ea4f-46c2-b48b-63298c28d102
Commercial Distribution StatusIn Commercial Distribution
Brand NameNovoKnee Total Knee System
Version Model Number3115-1101
Catalog Number3115-1101
Company DUNS081034828
Company NameNOVOSOURCE, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone3045542167
Emailinfo@novosource.com
Phone3045542167
Emailinfo@novosource.com
Phone3045542167
Emailinfo@novosource.com
Phone3045542167
Emailinfo@novosource.com
Phone3045542167
Emailinfo@novosource.com
Phone3045542167
Emailinfo@novosource.com
Phone3045542167
Emailinfo@novosource.com
Phone3045542167
Emailinfo@novosource.com
Phone3045542167
Emailinfo@novosource.com
Phone3045542167
Emailinfo@novosource.com
Phone3045542167
Emailinfo@novosource.com
Phone3045542167
Emailinfo@novosource.com
Phone3045542167
Emailinfo@novosource.com
Phone3045542167
Emailinfo@novosource.com
Phone3045542167
Emailinfo@novosource.com
Phone3045542167
Emailinfo@novosource.com
Phone3045542167
Emailinfo@novosource.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100811382039089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00811382039089]

Moist Heat or Steam Sterilization

[00811382039089]

Moist Heat or Steam Sterilization

[00811382039089]

Moist Heat or Steam Sterilization

[00811382039089]

Moist Heat or Steam Sterilization

[00811382039089]

Moist Heat or Steam Sterilization

[00811382039089]

Moist Heat or Steam Sterilization

[00811382039089]

Moist Heat or Steam Sterilization

[00811382039089]

Moist Heat or Steam Sterilization

[00811382039089]

Moist Heat or Steam Sterilization

[00811382039089]

Moist Heat or Steam Sterilization

[00811382039089]

Moist Heat or Steam Sterilization

[00811382039089]

Moist Heat or Steam Sterilization

[00811382039089]

Moist Heat or Steam Sterilization

[00811382039089]

Moist Heat or Steam Sterilization

[00811382039089]

Moist Heat or Steam Sterilization

[00811382039089]

Moist Heat or Steam Sterilization

[00811382039089]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-28
Device Publish Date2023-08-18

On-Brand Devices [NovoKnee Total Knee System]

00811382037047NK Knee Case 3 CR
00811382037030NK Knee Case 2 CR
00811382037009NK Knee Case 2
00811382036996NK Knee Case 1
00811382036989NK Knee Case 3
00811382036972Patellar Resection Clamp Foot
00811382036965Vernier Caliper
00811382036903Patellar Drill Guide
00811382036873Patella 38mm Trial
00811382036866Patella 35mm Trial
00811382036859Patella 32mm Trial
00811382036842Patella 29mm Trial
00811382036811UC Tibial Insert Size 6 18mm Trial
00811382036804UC Tibial Insert Size 5 18mm Trial
00811382036798UC Tibial Insert Size 4 18mm Trial
00811382036781UC Tibial Insert Size 3 18mm Trial
00811382036774UC Tibial Insert Size 2 18mm Trial
00811382036767UC Tibial Insert Size 1 18mm Trial
00811382036750UC Tibial Insert Size 6 15mm Trial
00811382036743UC Tibial Insert Size 5 15mm Trial
00811382036736UC Tibial Insert Size 4 15mm Trial
00811382036729UC Tibial Insert Size 3 15mm Trial
00811382036712UC Tibial Insert Size 2 15mm Trial
00811382036705UC Tibial Insert Size 1 15mm Trial
00811382036699UC Tibial Insert Size 6 13mm Trial
00811382036682UC Tibial Insert Size 5 13mm Trial
00811382036675UC Tibial Insert Size 4 13mm Trial
00811382036668UC Tibial Insert Size 3 13mm Trial
00811382036651UC Tibial Insert Size 2 13mm Trial
00811382036644UC Tibial Insert Size 1 13mm Trial
00811382036637UC Tibial Insert Size 6 11mm Trial
00811382036620UC Tibial Insert Size 5 11mm Trial
00811382036613UC Tibial Insert Size 4 11mm Trial
00811382036606UC Tibial Insert Size 3 11mm Trial
00811382036590UC Tibial Insert Size 2 11mm Trial
00811382036583UC Tibial Insert Size 1 11mm Trial
00811382036576UC Tibial Insert Size 6 9mm Trial
00811382036569UC Tibial Insert Size 5 9mm Trial
00811382036552UC Tibial Insert Size 4 9mm Trial
00811382036545UC Tibial Insert Size 3 9mm Trial
00811382036538UC Tibial Insert Size 2 9mm Trial
00811382036521UC Tibial Insert Size 1 9mm Trial
00811382036514HC PS Tibial Insert Size 6 18mm Trial
00811382036507HC PS Tibial Insert Size 5 18mm Trial
00811382036491HC PS Tibial Insert Size 4 18mm Trial
00811382036484HC PS Tibial Insert Size 3 18mm Trial
00811382036477HC PS Tibial Insert Size 2 18mm Trial
00811382036460HC PS Tibial Insert Size 1 18mm Trial
00811382036453HC PS Tibial Insert Size 6 15mm Trial
00811382036446HC PS Tibial Insert Size 5 15mm Trial
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