Klassic Tibial Insert, PS-Max, Std Poly

GUDID 00819251028417

Tibial Insert, PS-Max, Std Poly, Size 5, 24mm

TOTAL JOINT ORTHOPEDICS, INC.

Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis
Primary Device ID00819251028417
NIH Device Record Key120afbee-08b5-48a4-965a-fc1b2a17949a
Commercial Distribution StatusIn Commercial Distribution
Brand NameKlassic Tibial Insert, PS-Max, Std Poly
Version Model Number6300.05.024
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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

Device Dimensions

Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100819251028417 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00819251028417]

Radiation Sterilization

[00819251028417]

Radiation Sterilization

[00819251028417]

Radiation Sterilization

[00819251028417]

Radiation Sterilization

[00819251028417]

Radiation Sterilization

[00819251028417]

Radiation Sterilization

[00819251028417]

Radiation Sterilization

[00819251028417]

Radiation Sterilization

[00819251028417]

Radiation Sterilization

[00819251028417]

Radiation Sterilization

[00819251028417]

Radiation Sterilization

[00819251028417]

Radiation Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-10
Device Publish Date2020-12-02

On-Brand Devices [Klassic Tibial Insert, PS-Max, Std Poly ]

00819251028523Tibial Insert, PS-Max, Std Poly, Size 6, 24mm
00819251028516Tibial Insert, PS-Max, Std Poly, Size 6, 22mm
00819251028509Tibial Insert, PS-Max, Std Poly, Size 6, 21mm
00819251028493Tibial Insert, PS-Max, Std Poly, Size 6, 20mm
00819251028486Tibial Insert, PS-Max, Std Poly, Size 6, 18mm
00819251028479Tibial Insert, PS-Max, Std Poly, Size 6, 16mm
00819251028462Tibial Insert, PS-Max, Std Poly, Size 6, 14mm
00819251028455Tibial Insert, PS-Max, Std Poly, Size 6, 13mm
00819251028448Tibial Insert, PS-Max, Std Poly, Size 6, 12mm
00819251028431Tibial Insert, PS-Max, Std Poly, Size 6, 11mm
00819251028424Tibial Insert, PS-Max, Std Poly, Size 6, 10mm
00819251028417Tibial Insert, PS-Max, Std Poly, Size 5, 24mm
00819251028400Tibial Insert, PS-Max, Std Poly, Size 5, 22mm
00819251028394Tibial Insert, PS-Max, Std Poly, Size 5, 21mm
00819251028387Tibial Insert, PS-Max, Std Poly, Size 5, 20mm
00819251028370Tibial Insert, PS-Max, Std Poly, Size 5, 18mm
00819251028363Tibial Insert, PS-Max, Std Poly, Size 5, 16mm
00819251028356Tibial Insert, PS-Max, Std Poly, Size 5, 14mm
00819251028349Tibial Insert, PS-Max, Std Poly, Size 5, 13mm
00819251028332Tibial Insert, PS-Max, Std Poly, Size 5, 12mm
00819251028325Tibial Insert, PS-Max, Std Poly, Size 5, 11mm
00819251028318Tibial Insert, PS-Max, Std Poly, Size 5, 10mm
00819251028301Tibial Insert, PS-Max, Std Poly, Size 4, 24mm
00819251028295Tibial Insert, PS-Max, Std Poly, Size 4, 22mm
00819251028288Tibial Insert, PS-Max, Std Poly, Size 4, 21mm
00819251028271Tibial Insert, PS-Max, Std Poly, Size 4, 20mm
00819251028264Tibial Insert, PS-Max, Std Poly, Size 4, 18mm
00819251028257Tibial Insert, PS-Max, Std Poly, Size 4, 16mm
00819251028240Tibial Insert, PS-Max, Std Poly, Size 4, 14mm
00819251028233Tibial Insert, PS-Max, Std Poly, Size 4, 13mm
00819251028226Tibial Insert, PS-Max, Std Poly, Size 4, 12mm
00819251028219Tibial Insert, PS-Max, Std Poly, Size 4, 11mm
00819251028202Tibial Insert, PS-Max, Std Poly, Size 4, 10mm
00819251028196Tibial Insert, PS-Max, Std Poly, Size 3, 24mm
00819251028189Tibial Insert, PS-Max, Std Poly, Size 3, 22mm
00819251028172Tibial Insert, PS-Max, Std Poly, Size 3, 21mm
00819251028165Tibial Insert, PS-Max, Std Poly, Size 3, 20mm
00819251028158Tibial Insert, PS-Max, Std Poly, Size 3, 18mm
00819251028141Tibial Insert, PS-Max, Std Poly, Size 3, 16mm
00819251028134Tibial Insert, PS-Max, Std Poly, Size 3, 14mm
00819251028127Tibial Insert, PS-Max, Std Poly, Size 3, 13mm
00819251028110Tibial Insert, PS-Max, Std Poly, Size 3, 12mm
00819251028103Tibial Insert, PS-Max, Std Poly, Size 3, 11mm
00819251028097Tibial Insert, PS-Max, Std Poly, Size 3, 10mm
00819251028080Tibial Insert, PS-Max, Std Poly, Size 2, 24mm
00819251028073Tibial Insert, PS-Max, Std Poly, Size 2, 22mm
00819251028066Tibial Insert, PS-Max, Std Poly, Size 2, 21mm
00819251028059Tibial Insert, PS-Max, Std Poly, Size 2, 20mm
00819251028042Tibial Insert, PS-Max, Std Poly, Size 2, 18mm
00819251028035Tibial Insert, PS-Max, Std Poly, Size 2, 16mm
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