BKS Revision

GUDID 00822409103027

Neutral Tibial Tray Size 3

Ortho Development Corporation

Uncoated knee tibia prosthesis, metallic
Primary Device ID00822409103027
NIH Device Record Key3506f5bf-2b4f-494c-8879-47637cbdb286
Commercial Distribution StatusIn Commercial Distribution
Brand NameBKS Revision
Version Model Number562-1300A
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100822409103027 [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 Date2021-11-01
Device Publish Date2021-10-22

On-Brand Devices [BKS Revision]

00822409110421Modular Tibial Tray Neutral Size 7
00822409103065Neutral Tibial Tray Size 7
00822409103058Neutral Tibial Tray Size 6
00822409103041Neutral Tibial Tray Size 5
00822409103034Neutral Tibial Tray Size 4
00822409103027Neutral Tibial Tray Size 3
00822409103010Neutral Tibial Tray Size 2
00822409103003Neutral Tibial Tray Size 1

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