Balanced Knee Revision System

GUDID 00822409040452

Fluted Stem Ext Diameter 13mm x 150mm

Ortho Development Corporation

Knee stem
Primary Device ID00822409040452
NIH Device Record Keydd566896-2488-400b-b5c7-24b1ef9125e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameBalanced Knee Revision System
Version Model Number569-1315
Company DUNS876542390
Company NameOrtho Development Corporation
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 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
Phone+1(801)553-9991
Emailcustomerservice@odev.com

Device Dimensions

Length150 Millimeter
Length150 Millimeter
Length150 Millimeter
Length150 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100822409040452 [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 Date2018-12-07
Device Publish Date2018-11-06

On-Brand Devices [Balanced Knee Revision System]

00822409040728Slotted Stem Ext Diameter 24mm x 150mm
00822409040711Slotted Stem Ext Diameter 24mm x 110mm
00822409040704Slotted Stem Ext Diameter 24mm x 80mm
00822409040698Slotted Stem Ext Diameter 22mm x 150mm
00822409040681Slotted Stem Ext Diameter 22mm x 110mm
00822409040674Slotted Stem Ext Diameter 22mm x 80mm
00822409040667Slotted Stem Ext Diameter 20mm x 150mm
00822409040650Slotted Stem Ext Diameter 20mm x 110mm
00822409040643Slotted Stem Ext Diameter 20mm x 80mm
00822409040636Slotted Stem Ext Diameter 19mm x 150mm
00822409040629Slotted Stem Ext Diameter 19mm x 110mm
00822409040612Slotted Stem Ext Diameter 19mm x 80mm
00822409040605Slotted Stem Ext Diameter 18mm x 150mm
00822409040599Slotted Stem Ext Diameter 18mm x 110mm
00822409040582Slotted Stem Ext Diameter 18mm x 80mm
00822409040575Slotted Stem Ext Diameter 17mm x 150mm
00822409040568Slotted Stem Ext Diameter 17mm x 110mm
00822409040551Slotted Stem Ext Diameter 17mm x 80mm
00822409040544Slotted Stem Ext Diameter 16mm x 150mm
00822409040537Slotted Stem Ext Diameter 16mm x 110mm
00822409040520Slotted Stem Ext Diameter 16mm x 80mm
00822409040513Slotted Stem Ext Diameter 15mm x 150mm
00822409040506Slotted Stem Ext Diameter 15mm x 110mm
00822409040490Slotted Stem Ext Diameter 15mm x 80mm
00822409040483Slotted Stem Ext Diameter 14mm x 150mm
00822409040476Slotted Stem Ext Diameter 14mm x 110mm
00822409040469Slotted Stem Ext Diameter 14mm x 80mm
00822409040452Fluted Stem Ext Diameter 13mm x 150mm
00822409040445Fluted Stem Ext Diameter 13mm x 110mm
00822409040438Fluted Stem Ext Diameter 13mm x 80mm
00822409040421Fluted Stem Ext Diameter 12mm x 150mm
00822409040414Fluted Stem Ext Diameter 12mm x 110mm
00822409040407Fluted Stem Ext Diameter 12mm x 80mm
00822409040391Fluted Stem Ext Diameter 11mm x 150mm
00822409040384Fluted Stem Ext Diameter 11mm x 110mm
00822409040377Fluted Stem Ext Diameter 11mm x 80mm
00822409040360Fluted Stem Ext Diameter 10mm x 150mm
00822409040353Fluted Stem Ext Diameter 10mm x 110mm
00822409040346Fluted Stem Ext Diameter 10mm x 80mm
00822409040339Offset Tibial Tray Sz 7
00822409040322Offset Tibial Tray Sz 6
00822409040315Offset Tibial Tray Sz 5
00822409040308Offset Tibial Tray Sz 4
00822409040292Offset Tibial Tray Sz 3
00822409040285Offset Tibial Tray Sz 2
00822409040278Offset Tibial Tray Sz 1
00822409040261Sloped Tibial Tray Size 7
00822409040254Sloped Tibial Tray Size 6
00822409040247Sloped Tibial Tray Size 5
00822409040230Sloped Tibial Tray Size 4

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