Primary Device ID | 00814703016486 |
NIH Device Record Key | d3c2e049-5e54-4db9-894d-f9c1c5f9b1f3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Klassic Tibial Insert, PS-Post, E-Link Poly |
Version Model Number | 5305.04.018 |
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 |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com | |
Phone | 801-486-6070 |
udi@tjoinc.com |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
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 |
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 | 00814703016486 [Primary] |
JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
Steralize Prior To Use | true |
Device Is Sterile | true |
[00814703016486]
Ethylene Oxide
[00814703016486]
Ethylene Oxide
[00814703016486]
Ethylene Oxide
[00814703016486]
Ethylene Oxide
[00814703016486]
Ethylene Oxide
[00814703016486]
Ethylene Oxide
[00814703016486]
Ethylene Oxide
[00814703016486]
Ethylene Oxide
[00814703016486]
Ethylene Oxide
[00814703016486]
Ethylene Oxide
[00814703016486]
Ethylene Oxide
[00814703016486]
Ethylene Oxide
[00814703016486]
Ethylene Oxide
[00814703016486]
Ethylene Oxide
[00814703016486]
Ethylene Oxide
[00814703016486]
Ethylene Oxide
[00814703016486]
Ethylene Oxide
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-09-21 |
Device Publish Date | 2023-09-13 |
00814703019289 | Tibial Insert, PS-Post, E-Link, Size 6, 24mm |
00814703019272 | Tibial Insert, PS-Post, E-Link, Size 6, 21mm |
00814703019265 | Tibial Insert, PS-Post, E-Link, Size 5, 24mm |
00814703019258 | Tibial Insert, PS-Post, E-Link, Size 5, 21mm |
00814703019241 | Tibial Insert, PS-Post, E-Link, Size 4, 24mm |
00814703019234 | Tibial Insert, PS-Post, E-Link, Size 4, 21mm |
00814703019227 | Tibial Insert, PS-Post, E-Link, Size 3, 24mm |
00814703019210 | Tibial Insert, PS-Post, E-Link, Size 3, 21mm |
00814703019203 | Tibial Insert, PS-Post, E-Link, Size 2, 24mm |
00814703019197 | Tibial Insert, PS-Post, E-Link, Size 2, 21mm |
00814703019180 | Tibial Insert, PS-Post, E-Link, Size 1, 24mm |
00814703019173 | Tibial Insert, PS-Post, E-Link, Size 1, 21mm |
00814703016622 | Tibial Insert, PS-Post, E-Link, Size 6, 18mm |
00814703016554 | Tibial Insert, PS-Post, E-Link, Size 5, 18mm |
00814703016486 | Tibial Insert, PS-Post, E-Link, Size 4, 18mm |
00814703016417 | Tibial Insert, PS-Post, E-Link, Size 3, 18mm |
00814703016349 | Tibial Insert, PS-Post, E-Link, Size 2, 18mm |
00814703016271 | Tibial Insert, PS-Post, E-Link, Size 1, 18mm |