Anterior Starter Broach

GUDID 00819251020497

Anterior Starter Broach

TOTAL JOINT ORTHOPEDICS, INC.

Orthopaedic broach
Primary Device ID00819251020497
NIH Device Record Key0278ef19-cb72-47a6-a5a9-0aba3a643601
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnterior Starter Broach
Version Model Number1115.00.000
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 Batchtrue
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

Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100819251020497 [Primary]

FDA Product Code

HTQBroach
LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


[00819251020497]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-08
Device Publish Date2024-04-30

Devices Manufactured by TOTAL JOINT ORTHOPEDICS, INC.

00810094692674 - Klassic Knee Template, Tibial Baseplate, Revision2026-01-15 Klassic Knee Template, Tibial Baseplate, Revision
00810094692476 - Narrow Distal Femur Cut Block2025-09-04 Narrow Distal Femur Cut Block
00810094692544 - Klassic ONE Universal Cone & Revision Baseplate Tray, Baseplate Insert2025-08-05 Cone & Revision Baseplate Instrumentation Tray, Baseplate Insert
00810094692339 - Acetabular Reamer Adapter2025-07-04
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

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.