Balanced Knee System

GUDID 00822409030385

RT Size 7 Femoral PS-C Nonporous

Ortho Development Corporation

Uncoated knee femur prosthesis, metallic

Primary Device ID	00822409030385
NIH Device Record Key	efe04243-d835-42b6-902b-3d7bb664b385
Commercial Distribution Status	In Commercial Distribution
Brand Name	Balanced Knee System
Version Model Number	161-1704A
Company DUNS	876542390
Company Name	Ortho Development Corporation
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(801)553-9991
Email	customerservice@odev.com
Phone	+1(801)553-9991
Email	customerservice@odev.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409030385 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K994370

FDA Product Code

JWH	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-12-11
Device Publish Date	2015-10-23

On-Brand Devices [Balanced Knee System]

00822409035441	RT Size 3 Narrow Femoral CR Nonporous
00822409035434	LT Size 3 Narrow Femoral CR Nonporous
00822409035427	RT Size 4 Wide Femoral PS Nonporous
00822409035410	LT Size 4 Wide Femoral PS Nonporous
00822409035403	RT Size 3 Narrow Femoral PS Nonporous
00822409035397	LT Size 3 Narrow Femoral PS Nonporous
00822409030583	RT Size 7 Femoral CR Nonporous
00822409030576	LT Size 7 Femoral CR Nonporous
00822409030569	RT Size 6 Femoral CR Nonporous
00822409030552	LT Size 6 Femoral CR Nonporous
00822409030545	RT Size 5 Narrow Femoral CR Nonporous
00822409030538	LT Size 5 Narrow Femoral CR Nonporous
00822409030521	RT Size 5 Femoral CR Nonporous
00822409030514	LT Size 5 Femoral CR Nonporous
00822409030507	RT Size 4 Narrow Femoral CR Nonporous
00822409030491	LT Size 4 Narrow Femoral CR Nonporous
00822409030484	RT Size 4 Femoral CR Nonporous
00822409030477	LT Size 4 Femoral CR Nonporous
00822409030460	RT Size 3 Narrow Femoral CR Nonporous
00822409030453	LT Size 3 Narrow Femoral CR Nonporous
00822409030446	RT Size 3 Femoral CR Nonporous
00822409030439	LT Size 3 Femoral CR Nonporous
00822409030422	RT Size 2 Femoral CR Nonporous
00822409030415	LT Size 2 Femoral CR Nonporous
00822409030408	RT Size 1 Femoral CR Nonporous
00822409030392	LT Size 1 Femoral CR Nonporous
00822409030385	RT Size 7 Femoral PS-C Nonporous
00822409030378	LT Size 7 Femoral PS-C Nonporous
00822409030361	RT Size 7 Femoral PS Nonporous
00822409030354	LT Size 7 Femoral PS Nonporous
00822409030347	RT Size 6 Femoral PS-C Nonporous
00822409030330	LT Size 6 Femoral PS-C Nonporous
00822409030323	RT Size 6 Femoral PS Nonporous
00822409030316	LT Size 6 Femoral PS Nonporous
00822409030309	RT Size 5 Narrow Femoral PS Nonporous
00822409030293	LT Size 5 Narrow Femoral PS Nonporous
00822409030286	RT Size 5 Femoral PS-C Nonporous
00822409030279	LT Size 5 Femoral PS-C Nonporous
00822409030262	RT Size 5 Femoral PS Nonporous
00822409030255	LT Size 5 Femoral PS Nonporous
00822409030248	RT Size 4 Narrow Femoral PS Nonporous
00822409030231	LT Size 4 Narrow Femoral PS Nonporous
00822409030224	RT Size 4 Femoral PS-C Nonporous
00822409030217	LT Size 4 Femoral PS-C Nonporous
00822409030200	RT Size 4 Femoral PS Nonporous
00822409030194	LT Size 4 Femoral PS Nonporous
00822409030187	RT Size 3 Narrow Femoral PS Nonporous
00822409030170	LT Size 3 Narrow Femoral PS Nonporous
00822409030163	RT Size 3 Femoral PS-C Nonporous
00822409030156	LT Size 3 Femoral PS-C Nonporous