Spline Wrench, Closed

GUDID 00810094692322

TOTAL JOINT ORTHOPEDICS, INC.

Surgical torque wrench, reusable

• Primary Device ID: 00810094692322
• NIH Device Record Key: 27031659-421f-466f-8267-82b39a2ee778
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spline Wrench, Closed
• Version Model Number: 2017.00.100
• Company DUNS: 078416717
• Company Name: TOTAL JOINT ORTHOPEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 801-486-6070
• Email: bsiddoway@tjoinc.com
• Phone: 801-486-6070
• Email: bsiddoway@tjoinc.com
• Phone: 801-486-6070
• Email: bsiddoway@tjoinc.com
• Phone: 801-486-6070
• Email: bsiddoway@tjoinc.com
• Phone: 801-486-6070
• Email: bsiddoway@tjoinc.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810094692322 [Primary]

FDA Product Code

• HXC: Wrench

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00810094692322]

Moist Heat or Steam Sterilization

[00810094692322]

Moist Heat or Steam Sterilization

[00810094692322]

Moist Heat or Steam Sterilization

[00810094692322]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-22
• Device Publish Date: 2025-05-14

Devices Manufactured by TOTAL JOINT ORTHOPEDICS, INC.

• 00810094691790 - Klassic Knee Templates, Stem Extensions: 2025-05-22 Knee Templates, Stem Extensions
• 00810094692322 - Spline Wrench, Closed: 2025-05-22
• 00810094692322 - Spline Wrench, Closed: 2025-05-22
• 00810094692346 - Intramedullary Reamer, Revision: 2025-05-22 Intramedullary Reamer, Revision, Sz 10
• 00810094692353 - Intramedullary Reamer, Revision: 2025-05-22 Intramedullary Reamer, Revision, Sz 11
• 00810094692360 - Intramedullary Reamer, Revision: 2025-05-22 Intramedullary Reamer, Revision, Sz 12
• 00810094692377 - Intramedullary Reamer, Revision: 2025-05-22 Intramedullary Reamer, Revision, Sz 13
• 00810094692384 - Intramedullary Reamer, Revision: 2025-05-22 Intramedullary Reamer, Revision, Sz 14
• 00810094692391 - Intramedullary Reamer, Revision: 2025-05-22 Intramedullary Reamer, Revision, Sz 15