Balanced Knee System

GUDID 00822409041039

PS Vitamin E Insert Sz 3 16mm

Ortho Development Corporation

Tibial insert
Primary Device ID00822409041039
NIH Device Record Keybdc88725-06e2-43f2-ba18-eaa68d9a3e5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBalanced Knee System
Version Model Number163-5316
Company DUNS876542390
Company NameOrtho Development Corporation
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Dimensions

Height16 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100822409041039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-05
Device Publish Date2019-05-28

On-Brand Devices [Balanced Knee System]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.