Modular Cone Reamer, Handle

GUDID 00810094691905

TOTAL JOINT ORTHOPEDICS, INC.

Acetabular orthopaedic reamer
Primary Device ID00810094691905
NIH Device Record Key3192fabd-3a5d-481e-828f-74e1247cc7ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameModular Cone Reamer, Handle
Version Model Number2019.00.000
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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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
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
Phone8014866070
Emailkcardall@tjoinc.com

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
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
GS100810094691905 [Primary]

FDA Product Code

HTOReamer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810094691905]

Moist Heat or Steam Sterilization


[00810094691905]

Moist Heat or Steam Sterilization


[00810094691905]

Moist Heat or Steam Sterilization


[00810094691905]

Moist Heat or Steam Sterilization


[00810094691905]

Moist Heat or Steam Sterilization


[00810094691905]

Moist Heat or Steam Sterilization


[00810094691905]

Moist Heat or Steam Sterilization


[00810094691905]

Moist Heat or Steam Sterilization


[00810094691905]

Moist Heat or Steam Sterilization


[00810094691905]

Moist Heat or Steam Sterilization


[00810094691905]

Moist Heat or Steam Sterilization


[00810094691905]

Moist Heat or Steam Sterilization


[00810094691905]

Moist Heat or Steam Sterilization


[00810094691905]

Moist Heat or Steam Sterilization


[00810094691905]

Moist Heat or Steam Sterilization


[00810094691905]

Moist Heat or Steam Sterilization


[00810094691905]

Moist Heat or Steam Sterilization


[00810094691905]

Moist Heat or Steam Sterilization


[00810094691905]

Moist Heat or Steam Sterilization


[00810094691905]

Moist Heat or Steam Sterilization


[00810094691905]

Moist Heat or Steam Sterilization


Device Entry Metadata

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

Devices Manufactured by TOTAL JOINT ORTHOPEDICS, INC.

00810094701246 - Klassic Tibial Baseplate, Revision2025-05-15 Tibial Baseplate, Revision, Sz 1
00810094701307 - Klassic Tibial Baseplate, Revision2025-05-15 Tibial Baseplate Assembly, Revision, Sz 1 This contains the following implant numbers: 6200.01.000 Klassic Tibial Baseplate, Rev
00810094692278 - Universal Cone Impactor Head2025-05-02 Cone Impactor Head, Size 1-2, 12°
00810094692285 - Universal Cone Impactor Head2025-05-02 Cone Impactor Head, Size 3-4, 18°
00810094692292 - Universal Cone Impactor Head2025-05-02 Cone Impactor Head, Size 5-7, 24°
00810094692308 - Cone Reamer Guide2025-05-02 Cone Reamer Guide, 100mm
00810094692315 - Cone Reamer Guide2025-05-02 Cone Reamer Guide, 75mm
00810094692452 - Klassic ONE Universal Cone & Revision Baseplate Instrumentation Tray2025-05-02 Cone & Revision Baseplate Instrumentation Tray

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