Balance Knee Revision System

GUDID 00822409004539

Size 4 10mm Tibial Insert CK

Ortho Development Corporation

Tibial insert
Primary Device ID00822409004539
NIH Device Record Keyd2c0aeab-f91a-4ea7-bc20-a9a1c19c4488
Commercial Distribution StatusIn Commercial Distribution
Brand NameBalance Knee Revision System
Version Model Number563-1410
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
Phone+1(801)553-9991
Emailcustomerservice@odev.com

Device Dimensions

Height10 Millimeter
Height10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100822409004539 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-08-31

On-Brand Devices [Balance Knee Revision System]

00822409006502Size 6 Modular Tibial Tray Offset
00822409006496Size 5 Modular Tibial Tray Offset
00822409006489Size 4 Modular Tibial Tray Offset
00822409006472Size 3 Modular Tibial Tray Offset
00822409006465Size 2 Modular Tibial Tray Offset
00822409006458Size 1 Modular Tibial Tray Offset
008224090064417mm Offset Adapter
008224090064345mm Offset Adapter
008224090064273mm Offset Adapter
00822409006410Offset Adapter Screw
008224090064030mm Offset Adapter
00822409005628Size 7 Femoral Augment Posterior 8mm
00822409005611Size 7 Femoral Augment Posterior 4mm
00822409005604Size 6 Femoral Augment Posterior 8mm
00822409005598Size 6 Femoral Augment Posterior 4mm
00822409005581Size 5 Femoral Augment Posterior 8mm
00822409005574Size 5 Femoral Augment Posterior 4mm
00822409005567Size 4 Femoral Augment Posterior 8mm
00822409005550Size 4 Femoral Augment Posterior 4mm
00822409005543Size 3 Femoral Augment Posterior 8mm
00822409005536Size 3 Femoral Augment Posterior 4mm
00822409005529Size 2 Femoral Augment Posterior 8mm
00822409005512Size 2 Femoral Augment Posterior 4mm
00822409005505Size 1 Femoral Augment Posterior 8mm
00822409005499Size 1 Femoral Augment Posterior 4mm
00822409005482Size 7 Femoral Augment Distal 12mm
00822409005475Size 7 Femoral Augment Distal 8mm
00822409005468Size 7 Femoral Augment Distal 4mm
00822409005451Size 6 Femoral Augment Distal 12mm
00822409005444Size 6 Femoral Augment Distal 8mm
00822409005437Size 6 Femoral Augment Distal 4mm
00822409005420Size 5 Femoral Augment Distal 12mm
00822409005413Size 5 Femoral Augment Distal 8mm
00822409005406Size 5 Femoral Augment Distal 4mm
00822409005390Size 4 Femoral Augment Distal 12mm
00822409005383Size 4 Femoral Augment Distal 8mm
00822409005376Size 4 Femoral Augment Distal 4mm
00822409005369Size 3 Femoral Augment Distal 12mm
00822409005352Size 3 Femoral Augment Distal 8mm
00822409005345Size 3 Femoral Augment Distal 4mm
00822409005338Size 2 Femoral Augment Distal 12mm
00822409005321Size 2 Femoral Augment Distal 8mm
00822409005314Size 2 Femoral Augment Distal 4mm
00822409005307Size 1 Femoral Augment Distal 8mm
00822409005291Size 1 Femoral Augment Distal 4mm
00822409005284Dia.24x150mm Stem Extension Fluted
00822409005277Dia.24x110mm Stem Extension Fluted
00822409005260Dia.24x80mm Stem Extension Fluted
00822409005253Dia.22x150mm Stem Extension Fluted
00822409005246Dia.22x110mm Stem Extension Fluted

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