Tibial Insert Trial, PS-Post, Klassic ONE

GUDID 00819251026680

Tibial Insert Trial,PS-Post, size 3, 11mm

TOTAL JOINT ORTHOPEDICS, INC.

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Primary Device ID00819251026680
NIH Device Record Key7342f1f8-47b9-4049-a500-391e38565f74
Commercial Distribution StatusIn Commercial Distribution
Brand NameTibial Insert Trial, PS-Post, Klassic ONE
Version Model Number2254.03.011
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
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
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
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
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
GS100819251026680 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00819251026680]

Moist Heat or Steam Sterilization


[00819251026680]

Moist Heat or Steam Sterilization


[00819251026680]

Moist Heat or Steam Sterilization


[00819251026680]

Moist Heat or Steam Sterilization


[00819251026680]

Moist Heat or Steam Sterilization


[00819251026680]

Moist Heat or Steam Sterilization


[00819251026680]

Moist Heat or Steam Sterilization


[00819251026680]

Moist Heat or Steam Sterilization


[00819251026680]

Moist Heat or Steam Sterilization


[00819251026680]

Moist Heat or Steam Sterilization


[00819251026680]

Moist Heat or Steam Sterilization


[00819251026680]

Moist Heat or Steam Sterilization


[00819251026680]

Moist Heat or Steam Sterilization


[00819251026680]

Moist Heat or Steam Sterilization


[00819251026680]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-19
Device Publish Date2020-10-09

On-Brand Devices [Tibial Insert Trial, PS-Post, Klassic ONE ]

00819251026901Tibial Insert Trial,PS-Post, size 6, 16mm
00819251026895Tibial Insert Trial,PS-Post, size 6, 14mm
00819251026888Tibial Insert Trial,PS-Post, size 6, 13mm
00819251026871Tibial Insert Trial,PS-Post, size 6, 12mm
00819251026864Tibial Insert Trial,PS-Post, size 6, 11mm
00819251026857Tibial Insert Trial,PS-Post, size 6, 10mm
00819251026840Tibial Insert Trial,PS-Post, size 5, 16mm
00819251026833Tibial Insert Trial,PS-Post, size 5, 14mm
00819251026826Tibial Insert Trial,PS-Post, size 5, 13mm
00819251026819Tibial Insert Trial,PS-Post, size 5, 12mm
00819251026802Tibial Insert Trial,PS-Post, size 5, 11mm
00819251026796Tibial Insert Trial,PS-Post, size 5, 10mm
00819251026789Tibial Insert Trial,PS-Post, size 4, 16mm
00819251026772Tibial Insert Trial,PS-Post, size 4, 14mm
00819251026765Tibial Insert Trial,PS-Post, size 4, 13mm
00819251026758Tibial Insert Trial,PS-Post, size 4, 12mm
00819251026741Tibial Insert Trial,PS-Post, size 4, 11mm
00819251026734Tibial Insert Trial,PS-Post, size 4, 10mm
00819251026727Tibial Insert Trial,PS-Post, size 3, 16mm
00819251026710Tibial Insert Trial,PS-Post, size 3, 14mm
00819251026703Tibial Insert Trial,PS-Post, size 3, 13mm
00819251026697Tibial Insert Trial,PS-Post, size 3, 12mm
00819251026680Tibial Insert Trial,PS-Post, size 3, 11mm
00819251026673Tibial Insert Trial,PS-Post, size 3, 10mm
00819251026666Tibial Insert Trial,PS-Post, size 2, 16mm
00819251026659Tibial Insert Trial,PS-Post, size 2, 14mm
00819251026642Tibial Insert Trial,PS-Post, size 2, 13mm
00819251026635Tibial Insert Trial,PS-Post, size 2, 12mm
00819251026628Tibial Insert Trial,PS-Post, size 2, 11mm
00819251026611Tibial Insert Trial,PS-Post, size 2, 10mm
00819251026604Tibial Insert Trial,PS-Post, size 1, 16mm
00819251026598Tibial Insert Trial,PS-Post, size 1, 14mm
00819251026581Tibial Insert Trial,PS-Post, size 1, 13mm
00819251026574Tibial Insert Trial,PS-Post, size 1, 12mm
00819251026567Tibial Insert Trial,PS-Post, size 1, 11mm
00819251026550Tibial Insert Trial,PS-Post, size 1, 10mm
00819251029575Tibial Insert Trial,PS-Post, size 6, 24mm
00819251029568Tibial Insert Trial,PS-Post, size 6, 21mm
00819251029551Tibial Insert Trial,PS-Post, size 6, 18mm
00819251029544Tibial Insert Trial,PS-Post, size 5, 24mm
00819251029537Tibial Insert Trial,PS-Post, size 5, 21mm
00819251029520Tibial Insert Trial,PS-Post, size 5, 18mm
00819251029513Tibial Insert Trial,PS-Post, size 4, 24mm
00819251029506Tibial Insert Trial,PS-Post, size 4, 21mm
00819251029490Tibial Insert Trial,PS-Post, size 4, 18mm
00819251029483Tibial Insert Trial,PS-Post, size 3, 24mm
00819251029476Tibial Insert Trial,PS-Post, size 3, 21mm
00819251029469Tibial Insert Trial,PS-Post, size 3, 18mm
00819251029452Tibial Insert Trial,PS-Post, size 2, 24mm
00819251029445Tibial Insert Trial,PS-Post, size 2, 21mm

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