Klassic Tibial Augment & Screw

GUDID 00810094701079

Knee arthroplasty wedge

Primary Device ID	00810094701079
NIH Device Record Key	57975542-db89-4a77-bfeb-e27c0e8b66f9
Commercial Distribution Status	In Commercial Distribution
Brand Name	Klassic Tibial Augment & Screw
Version Model Number	6405.01.010
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

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 Issuing Agency	Device ID
GS1	00810094701079 [Primary]

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

Steralize Prior To Use	true
Device Is Sterile	true

[00810094701079]

Radiation Sterilization

[00810094701079]

Radiation Sterilization

[00810094701079]

Radiation Sterilization

[00810094701079]

Radiation Sterilization

[00810094701079]

Radiation Sterilization

[00810094701079]

Radiation Sterilization

[00810094701079]

Radiation Sterilization

[00810094701079]

Radiation Sterilization

[00810094701079]

Radiation Sterilization

[00810094701079]

Radiation Sterilization

[00810094701079]

Radiation Sterilization

00810094701116	Includes: Tibial Augment, Size 5-6, 10mm (00810094701055) and Augment Screw, 10mm (0081470301997
00810094701109	Includes: Tibial Augment, Size 5-6, 5mm (00810094701048) and Augment Screw, 5mm (00814703019968)
00810094701093	Includes: Tibial Augment, Size 3-4, 10mm (00810094701031) and Augment Screw, 10mm (0081470301997
00810094701086	Includes: Tibial Augment, Size 3-4, 5mm (00810094701024) and Augment Screw, 5mm (00814703019968)
00810094701079	Includes: Tibial Augment, Size 1-2, 10mm (00810094701017) and Augment Screw, 10mm (0081470301997
00810094701062	Includes: Tibial Augment, Size 1-2, 5mm (00810094701000) and Augment Screw, 5mm (00814703019968)