Klassic Femoral Augment, Distal

GUDID 00810094700287

Femoral Augment, Distal, Size 1-2, 10mm

TOTAL JOINT ORTHOPEDICS, INC.

Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge

• Primary Device ID: 00810094700287
• NIH Device Record Key: 1ceeae53-5b6f-4def-afbc-1d052e1b41d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Klassic Femoral Augment, Distal
• Version Model Number: 6403.01.010
• 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	00810094700287 [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

[00810094700287]

Radiation Sterilization

[00810094700287]

Radiation Sterilization

[00810094700287]

Radiation Sterilization

[00810094700287]

Radiation Sterilization

[00810094700287]

Radiation Sterilization

[00810094700287]

Radiation Sterilization

[00810094700287]

Radiation Sterilization

[00810094700287]

Radiation Sterilization

[00810094700287]

Radiation Sterilization

[00810094700287]

Radiation Sterilization

[00810094700287]

Radiation Sterilization

[00810094700287]

Radiation Sterilization

[00810094700287]

Radiation Sterilization

[00810094700287]

Radiation Sterilization

[00810094700287]

Radiation Sterilization

[00810094700287]

Radiation Sterilization

[00810094700287]

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

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• 00810094700904: Femoral Augment, Distal, Size 3, 5mm
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• 00810094700386: Femoral Augment, Distal, Size 6-7, 10mm
• 00810094700379: Femoral Augment, Distal, Size 6-7, 5mm
• 00810094700362: Femoral Augment, Distal, Size 5-7, 10mm
• 00810094700355: Femoral Augment, Distal, Size 5-7, 5mm
• 00810094700348: Femoral Augment, Distal, Size 4-5, 10mm
• 00810094700331: Femoral Augment, Distal, Size 4-5, 5mm
• 00810094700324: Femoral Augment, Distal, Size 3-4, 10mm
• 00810094700317: Femoral Augment, Distal, Size 3-4, 5mm
• 00810094700300: Femoral Augment, Distal, Size 2-3, 10mm
• 00810094700294: Femoral Augment, Distal, Size 2-3, 5mm
• 00810094700287: Femoral Augment, Distal, Size 1-2, 10mm
• 00810094700270: Femoral Augment, Distal, Size 1-2, 5mm