22mm Femoral Head, 12/14 taper, +3.5mm offset

GUDID 00814703012143

TOTAL JOINT ORTHOPEDICS, INC.

Femoral head bipolar component Femoral head bipolar component Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty
Primary Device ID00814703012143
NIH Device Record Keyfb385f6e-9ca2-4c67-b2f3-4478343242bd
Commercial Distribution StatusIn Commercial Distribution
Brand Name22mm Femoral Head, 12/14 taper, +3.5mm offset
Version Model Number3200.22.350
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 BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100814703012143 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00814703012143]

Radiation Sterilization


[00814703012143]

Radiation Sterilization


[00814703012143]

Radiation Sterilization


[00814703012143]

Radiation Sterilization


[00814703012143]

Radiation Sterilization


[00814703012143]

Radiation Sterilization


[00814703012143]

Radiation Sterilization


[00814703012143]

Radiation Sterilization


[00814703012143]

Radiation Sterilization


[00814703012143]

Radiation Sterilization


[00814703012143]

Radiation Sterilization


[00814703012143]

Radiation Sterilization


[00814703012143]

Radiation Sterilization


[00814703012143]

Radiation Sterilization


[00814703012143]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-22

Devices Manufactured by TOTAL JOINT ORTHOPEDICS, INC.

00810094691851 - PS-Post Box Resection Guide2024-02-22 PS-Post Box Resection Guide, Size 1
00810094691868 - PS-Post Box Resection Guide2024-02-22 PS-Post Box Resection Guide, Size 2 and 3
00810094691875 - PS-Post Box Resection Guide2024-02-22 PS-Post Box Resection Guide, Size 4 and 5
00810094691882 - PS-Post Box Resection Guide2024-02-22 PS-Post Box Resection Guide, Size 6 and 7
00819251021197 - Femoral Stem Impactor with Anteversion 2023-12-19 Femoral Stem Impactor with Anteversion
00819251020503 - Acetabular Cup Sizer2023-12-05 Acetabular Cup Sizer, 48mm
00819251020510 - Acetabular Cup Sizer2023-12-05 Acetabular Cup Sizer, 50mm
00819251020527 - Acetabular Cup Sizer2023-12-05 Acetabular Cup Sizer, 52mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.