Intramedullary Resection Guide Adapter

GUDID 00810094692483

TOTAL JOINT ORTHOPEDICS, INC.

Orthopaedic reamer guide
Primary Device ID00810094692483
NIH Device Record Keya307c125-cb15-47f9-a68c-8ab9a77318a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntramedullary Resection Guide Adapter
Version Model Number2906.00.000
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

Phone801-486-6070
Emailbsiddoway@tjoinc.com
Phone801-486-6070
Emailbsiddoway@tjoinc.com
Phone801-486-6070
Emailbsiddoway@tjoinc.com
Phone801-486-6070
Emailbsiddoway@tjoinc.com
Phone801-486-6070
Emailbsiddoway@tjoinc.com
Phone801-486-6070
Emailbsiddoway@tjoinc.com
Phone801-486-6070
Emailbsiddoway@tjoinc.com
Phone801-486-6070
Emailbsiddoway@tjoinc.com
Phone801-486-6070
Emailbsiddoway@tjoinc.com
Phone801-486-6070
Emailbsiddoway@tjoinc.com
Phone801-486-6070
Emailbsiddoway@tjoinc.com
Phone801-486-6070
Emailbsiddoway@tjoinc.com
Phone801-486-6070
Emailbsiddoway@tjoinc.com
Phone801-486-6070
Emailbsiddoway@tjoinc.com
Phone801-486-6070
Emailbsiddoway@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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810094692483 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810094692483]

Moist Heat or Steam Sterilization


[00810094692483]

Moist Heat or Steam Sterilization


[00810094692483]

Moist Heat or Steam Sterilization


[00810094692483]

Moist Heat or Steam Sterilization


[00810094692483]

Moist Heat or Steam Sterilization


[00810094692483]

Moist Heat or Steam Sterilization


[00810094692483]

Moist Heat or Steam Sterilization


[00810094692483]

Moist Heat or Steam Sterilization


[00810094692483]

Moist Heat or Steam Sterilization


[00810094692483]

Moist Heat or Steam Sterilization


[00810094692483]

Moist Heat or Steam Sterilization


[00810094692483]

Moist Heat or Steam Sterilization


[00810094692483]

Moist Heat or Steam Sterilization


[00810094692483]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-22
Device Publish Date2025-05-14

Devices Manufactured by TOTAL JOINT ORTHOPEDICS, INC.

00810094691790 - Klassic Knee Templates, Stem Extensions2025-05-22 Knee Templates, Stem Extensions
00810094692322 - Spline Wrench, Closed2025-05-22
00810094692346 - Intramedullary Reamer, Revision2025-05-22 Intramedullary Reamer, Revision, Sz 10
00810094692353 - Intramedullary Reamer, Revision2025-05-22 Intramedullary Reamer, Revision, Sz 11
00810094692360 - Intramedullary Reamer, Revision2025-05-22 Intramedullary Reamer, Revision, Sz 12
00810094692377 - Intramedullary Reamer, Revision2025-05-22 Intramedullary Reamer, Revision, Sz 13
00810094692384 - Intramedullary Reamer, Revision2025-05-22 Intramedullary Reamer, Revision, Sz 14
00810094692391 - Intramedullary Reamer, Revision2025-05-22 Intramedullary Reamer, Revision, Sz 15

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