Balanced Knee System Revision

GUDID 00822409095650

Tibial Augment 5mm Block Rt. Lat/Lt Med Sz 3

Ortho Development Corporation

Knee arthroplasty wedge
Primary Device ID00822409095650
NIH Device Record Key93044d14-29d1-4c23-8a22-5f32b15c7696
Commercial Distribution StatusIn Commercial Distribution
Brand NameBalanced Knee System Revision
Version Model Number567-5103A
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
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com

Device Dimensions

Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100822409095650 [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 Date2021-02-02
Device Publish Date2021-01-25

On-Brand Devices [Balanced Knee System Revision]

00822409096244Femoral Augment Posterior Sz 7 8mm
00822409096237Femoral Augment Posterior Sz 7 4mm
00822409096220Femoral Augment Posterior Sz 7 2mm
00822409096213Femoral Augment Posterior Sz 6 8mm
00822409096206Femoral Augment Posterior Sz 6 4mm
00822409096190Femoral Augment Posterior Sz 6 2mm
00822409096183Femoral Augment Posterior Sz 5 8mm
00822409096176Femoral Augment Posterior Sz 5 4mm
00822409096169Femoral Augment Posterior Sz 5 2mm
00822409096152Femoral Augment Posterior Sz 4 8mm
00822409096145Femoral Augment Posterior Sz 4 4mm
00822409096138Femoral Augment Posterior Sz 4 2mm
00822409096121Femoral Augment Posterior Sz 3 8mm
00822409096114Femoral Augment Posterior Sz 3 4mm
00822409096107Femoral Augment Posterior Sz 3 2mm
00822409096091Femoral Augment Posterior Sz 2 8mm
00822409096084Femoral Augment Posterior Sz 2 4mm
00822409096077Femoral Augment Posterior Sz 2 2mm
00822409096060Femoral Augment Posterior Sz 1 8mm
00822409096053Femoral Augment Posterior Sz 1 4mm
00822409096046Femoral Augment Posterior Sz 1 2mm
00822409096039Femoral Augment Distal Sz 7 12mm
00822409096022Femoral Augment Distal Sz 7 8mm
00822409096015Femoral Augment Distal Sz 7 4mm
00822409096008Femoral Augment Distal Sz 6 12mm
00822409095995Femoral Augment Distal Sz 6 8mm
00822409095988Femoral Augment Distal Sz 6 4mm
00822409095971Femoral Augment Distal Sz 5 12mm
00822409095964Femoral Augment Distal Sz 5 8mm
00822409095957Femoral Augment Distal Sz 5 4mm
00822409095940Femoral Augment Distal Sz 4 12mm
00822409095933Femoral Augment Distal Sz 4 8mm
00822409095926Femoral Augment Distal Sz 4 4mm
00822409095919Femoral Augment Distal Sz 3 12mm
00822409095902Femoral Augment Distal Sz 3 8mm
00822409095896Femoral Augment Distal Sz 3 4mm
00822409095889Femoral Augment Distal Sz 2 12mm
00822409095872Femoral Augment Distal Sz 2 8mm
00822409095865Femoral Augment Distal Sz 2 4mm
00822409095858Femoral Augment Distal Sz 1 8mm
00822409095841Femoral Augment Distal Sz 1 4mm
00822409095834Tibial Augment 15mm Block Rt. Lat/Lt Med Sz 7
00822409095827Tibial Augment 15mm Block Rt. Lat/Lt Med Sz 6
00822409095810Tibial Augment 15mm Block Rt. Lat/Lt Med Sz 5
00822409095803Tibial Augment 15mm Block Rt. Lat/Lt Med Sz 4
00822409095797Tibial Augment 15mm Block Rt. Lat/Lt Med Sz 3
00822409095780Tibial Augment 15mm Block Rt. Lat/Lt Med Sz 2
00822409095773Tibial Augment 15mm Block Rt. Lat/Lt Med Sz 1
00822409095766Tibial Augment 10mm Block Rt. Lat/Lt Med Sz 7
00822409095759Tibial Augment 10mm Block Rt. Lat/Lt Med Sz 6

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