n/a

GUDID 00822409045013

Central Cone Tibial Tray Trial Size 3

Ortho Development Corporation

Knee tibia prosthesis trial Knee tibia prosthesis trial Knee tibia prosthesis trial Knee tibia prosthesis trial Knee tibia prosthesis trial Knee tibia prosthesis trial Knee tibia prosthesis trial Knee tibia prosthesis trial
Primary Device ID00822409045013
NIH Device Record Keya97a19b8-732b-488e-9923-e62426dc4c07
Commercial Distribution StatusIn Commercial Distribution
Brand Namen/a
Version Model Number662-7303
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100822409045013 [Primary]
GS100822409045013 [Primary]
GS100822409045013 [Primary]
GS100822409045013 [Primary]
GS100822409045013 [Primary]
GS100822409045013 [Primary]
GS100822409045013 [Primary]
GS100822409045013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00822409045013]

Moist Heat or Steam Sterilization


[00822409045013]

Moist Heat or Steam Sterilization


[00822409045013]

Moist Heat or Steam Sterilization


[00822409045013]

Moist Heat or Steam Sterilization


[00822409045013]

Moist Heat or Steam Sterilization


[00822409045013]

Moist Heat or Steam Sterilization


[00822409045013]

Moist Heat or Steam Sterilization


[00822409045013]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

On-Brand Devices [n/a]

00822409045082Straight Anterior Broach Handle
00822409044474CR Insert Trials Size 6
00822409044467CR Insert Trials Size 6
00822409044450CR Insert Trials Size 6
00822409044443CR Insert Trials Size 6
00822409044436CR Insert Trials Size 5
00822409044429CR Insert Trials Size 5
00822409044412CR Insert Trials Size 5
00822409044405CR Insert Trials Size 5
00822409044399CR Insert Trials Size 4
00822409044382CR Insert Trials Size 4
00822409044375CR Insert Trials Size 4
00822409044368CR Insert Trials Size 4
00822409044351CR Insert Trials Size 3
00822409044344CR Insert Trials Size 3
00822409044337CR Insert Trials Size 3
00822409044320CR Insert Trials Size 3
00822409044313CR Insert Trials Size 2
00822409044306CR Insert Trials Size 2
00822409044290CR Insert Trials Size 2
00822409044283CR Insert Trials Size 2
00822409044276Wingnut Patella Reaming Handle
00822409046546Single Offset Broach Handle
008224090465392mm Tibial Recut Block
00822409071630Threaded Collarless Pin 50mm
00822409071623Threaded Collared Pin 50mm
00822409071272TibTrialSpacer Lg Height 30mm
00822409071265TibTrialSpacer Lg Height 25mm
00822409071258TibTrialSpacer Lg Height 20mm
00822409071241TibTrialSpacer Lg Height18mm
00822409071234TibTrialSpacer Lg Height16mm
00822409071227TibTrialSpacer Lg Height14mm
00822409071210TibTrialSpacer Lg Height12mm
00822409071203TibTrialSpacer Lg Height10mm
00822409071197TibTrialSpacer Med Height30mm
00822409071180TibTrialSpacer Med Height25mm
00822409071173TibTrialSpacer Med Height20mm
00822409071166TibTrialSpacer Med Height18mm
00822409071159TibTrialSpacer Med Height16mm
00822409071142TibTrialSpacer Med Height14mm
00822409071135TibTrialSpacer Med Height12mm
00822409071128TibTrialSpacer Med Height10mm
00822409071111TibTrialSpacerSmall Height30mm
00822409071104TibTrialSpacerSmall Height25mm
00822409071098TibTrialSpacerSmall Height20mm
00822409071081TibTrialSpacerSmall Height18mm
00822409071074TibTrialSpacerSmall Height16mm
00822409071067TibTrialSpacerSmall Height14mm
00822409071050TibTrialSpacerSmall Height12mm
00822409071043TibTrialSpacerSmall Height10mm

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