Klassic Femoral Augment, Posterior

GUDID 00810094700188

Femoral Augment & Screw, Posterior, Size 3-4, 10mm

TOTAL JOINT ORTHOPEDICS, INC.

Knee arthroplasty wedge

• Primary Device ID: 00810094700188
• NIH Device Record Key: aa3c3646-ecaa-4ea2-ad90-349d55bfee9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Klassic Femoral Augment, Posterior
• Version Model Number: 6401.03.010
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com
• Phone: 801-486-6070
• Email: udi@tjoinc.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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
• 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
• 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
• 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
• 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	00810094700188 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230537

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

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

[00810094700188]

Radiation Sterilization

[00810094700188]

Radiation Sterilization

[00810094700188]

Radiation Sterilization

[00810094700188]

Radiation Sterilization

[00810094700188]

Radiation Sterilization

[00810094700188]

Radiation Sterilization

[00810094700188]

Radiation Sterilization

[00810094700188]

Radiation Sterilization

[00810094700188]

Radiation Sterilization

[00810094700188]

Radiation Sterilization

[00810094700188]

Radiation Sterilization

[00810094700188]

Radiation Sterilization

[00810094700188]

Radiation Sterilization

[00810094700188]

Radiation Sterilization

[00810094700188]

Radiation Sterilization

[00810094700188]

Radiation Sterilization

[00810094700188]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-11
• Device Publish Date: 2024-06-03

On-Brand Devices [Klassic Femoral Augment, Posterior]

• 00810094700850: Femoral Augment, Posterior, Size 7, 10mm
• 00810094700843: Femoral Augment, Posterior, Size 7, 5mm
• 00810094700836: Femoral Augment, Posterior, Size 6, 10mm
• 00810094700829: Femoral Augment, Posterior, Size 6, 5mm
• 00810094700812: Femoral Augment, Posterior, Size 5, 10mm
• 00810094700805: Femoral Augment, Posterior, Size 5, 5mm
• 00810094700799: Femoral Augment, Posterior, Size 4, 10mm
• 00810094700782: Femoral Augment, Posterior, Size 4, 5mm
• 00810094700775: Femoral Augment, Posterior, Size 3, 10mm
• 00810094700768: Femoral Augment, Posterior, Size 3, 5mm
• 00810094700751: Femoral Augment, Posterior, Size 2, 10mm
• 00810094700744: Femoral Augment, Posterior, Size 2, 5mm
• 00810094700737: Femoral Augment, Posterior, Size 1, 10mm
• 00810094700720: Femoral Augment, Posterior, Size 1, 5mm
• 00810094700263: Femoral Augment & Screw, Posterior, Size 7, 10mm
• 00810094700256: Femoral Augment & Screw, Posterior, Size 7, 5mm
• 00810094700249: Femoral Augment & Screw, Posterior, Size 6-7, 10mm
• 00810094700232: Femoral Augment & Screw, Posterior, Size 6-7, 5mm
• 00810094700225: Femoral Augment & Screw, Posterior, Size 5-7, 10mm
• 00810094700218: Femoral Augment & Screw, Posterior, Size 5-7, 5mm
• 00810094700201: Femoral Augment & Screw, Posterior, Size 4-5, 10mm
• 00810094700195: Femoral Augment & Screw, Posterior, Size 4-5, 5mm
• 00810094700188: Femoral Augment & Screw, Posterior, Size 3-4, 10mm
• 00810094700171: Femoral Augment & Screw, Posterior, Size 3-4, 5mm
• 00810094700164: Femoral Augment & Screw, Posterior, Size 2-3, 10mm
• 00810094700157: Femoral Augment & Screw, Posterior, Size 2-3, 5mm
• 00810094700140: Femoral Augment & Screw, Posterior, Size 1-2, 10mm
• 00810094700133: Femoral Augment & Screw, Posterior, Size 1-2, 5mm