Platform Neutral Acetabular Insert with E-Link

GUDID 00814703017124

Neutral Acetabular Insert with E-Link, 28mm head, size 46mm

TOTAL JOINT ORTHOPEDICS, INC.

Non-constrained polyethylene acetabular liner
Primary Device ID00814703017124
NIH Device Record Key2e401840-e214-4ecf-93e1-4a913e970ff7
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlatform Neutral Acetabular Insert with E-Link
Version Model Number3511.46.028
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
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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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100814703017124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00814703017124]

Ethylene Oxide


[00814703017124]

Ethylene Oxide


[00814703017124]

Ethylene Oxide


[00814703017124]

Ethylene Oxide


[00814703017124]

Ethylene Oxide


[00814703017124]

Ethylene Oxide


[00814703017124]

Ethylene Oxide


[00814703017124]

Ethylene Oxide


[00814703017124]

Ethylene Oxide


[00814703017124]

Ethylene Oxide


[00814703017124]

Ethylene Oxide


[00814703017124]

Ethylene Oxide


[00814703017124]

Ethylene Oxide


[00814703017124]

Ethylene Oxide


[00814703017124]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-06
Device Publish Date2022-09-28

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00814703017209Neutral Acetabular Insert with E-Link, 36mm head, size 58mm
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00814703017186Neutral Acetabular Insert with E-Link, 36mm head, size 54mm
00814703017179Neutral Acetabular Insert with E-Link, 36mm head, size 52mm
00814703017162Neutral Acetabular Insert with E-Link, 36mm head, size 50mm
00814703017155Neutral Acetabular Insert with E-Link, 32mm head, size 50mm
00814703017148Neutral Acetabular Insert with E-Link, 32mm head, size 48mm
00814703017131Neutral Acetabular Insert with E-Link, 32mm head, size 46mm
00814703017124Neutral Acetabular Insert with E-Link, 28mm head, size 46mm
00814703017117Neutral Acetabular Insert with E-Link, 28mm head, size 44mm

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