Universal Cone

GUDID 00810094700522

Cone, Size 6, 24 degree

TOTAL JOINT ORTHOPEDICS, INC.

Knee arthroplasty wedge
Primary Device ID00810094700522
NIH Device Record Key418b24e8-beca-433b-a828-33ae831e4a10
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal Cone
Version Model Number6800.06.024
Company DUNS078416717
Company NameTOTAL JOINT ORTHOPEDICS, INC.
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

Phone8014866070
Emailkcardall@tjoinc.com
Phone8014866070
Emailkcardall@tjoinc.com
Phone8014866070
Emailkcardall@tjoinc.com
Phone8014866070
Emailkcardall@tjoinc.com
Phone8014866070
Emailkcardall@tjoinc.com
Phone8014866070
Emailkcardall@tjoinc.com
Phone8014866070
Emailkcardall@tjoinc.com
Phone8014866070
Emailkcardall@tjoinc.com
Phone8014866070
Emailkcardall@tjoinc.com
Phone8014866070
Emailkcardall@tjoinc.com
Phone8014866070
Emailkcardall@tjoinc.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100810094700522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00810094700522]

Radiation Sterilization


[00810094700522]

Radiation Sterilization


[00810094700522]

Radiation Sterilization


[00810094700522]

Radiation Sterilization


[00810094700522]

Radiation Sterilization


[00810094700522]

Radiation Sterilization


[00810094700522]

Radiation Sterilization


[00810094700522]

Radiation Sterilization


[00810094700522]

Radiation Sterilization


[00810094700522]

Radiation Sterilization


[00810094700522]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-12
Device Publish Date2024-09-04

On-Brand Devices [Universal Cone]

00810094700539Cone, Size 7, 24 degree
00810094700522Cone, Size 6, 24 degree
00810094700515Cone, Size 5, 24 degree
00810094700508Cone, Size 4, 18 degree
00810094700492Cone, Size 3, 18 degree
00810094700485Cone, Size 2, 12 degree
00810094700478Cone, Size 1, 12 degree

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