Primary Device ID | 00843575111456 |
NIH Device Record Key | 4d9fac18-2ee7-4d0b-bc57-a62defc4fda4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MOBIO™ Total Knee System |
Version Model Number | 8829305212 |
Catalog Number | 8829305212 |
Company DUNS | 081315444 |
Company Name | B-ONE ORTHO, CORP. |
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 | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00843575111456 [Primary] |
JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
[00843575111456]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-06-28 |
Device Publish Date | 2021-06-18 |
00843575106438 | EM Tibial Alignment Guide, Non-Spiked Uprod, Standard |
00843575106421 | EM Tibial Alignment Guide, Spiked Uprod, Standard |
00843575106414 | PS+ Tibial Insert, Size HJ/7-10+, 25mm thickness, Vitamin E UHMWPE |
00843575106407 | PS+ Tibial Insert, Size HJ/7-10+, 22mm thickness, Vitamin E UHMWPE |
00843575106391 | PS+ Tibial Insert, Size FG/4-9+, 25mm thickness, Vitamin E UHMWPE |
00843575106384 | PS+ Tibial Insert, Size FG/4-9+, 22mm thickness, Vitamin E UHMWPE |
00843575106377 | PS+ Tibial Insert, Size DE/3-7+, 25mm thickness, Vitamin E UHMWPE |
00843575106360 | PS+ Tibial Insert, Size DE/3-7+, 22mm thickness, Vitamin E UHMWPE |
00843575106353 | PS+ Tibial Insert, Size BC/3-6+, 25mm thickness, Vitamin E UHMWPE |
00843575106346 | PS+ Tibial Insert, Size BC/3-6+, 22mm thickness, Vitamin E UHMWPE |
00843575106339 | PS+ Tibial Insert, Size A/3-4+, 25mm thickness, Vitamin E UHMWPE |
00843575106322 | PS+ Tibial Insert, Size A/3-4+, 22mm thickness, Vitamin E UHMWPE |
00843575106315 | PS+ Tibial Insert, Size A/1-2+, 25mm thickness, Vitamin E UHMWPE |
00843575106308 | PS+ Tibial Insert, Size A/1-2+, 22mm thickness, Vitamin E UHMWPE |
00843575106292 | PS Tibial Insert, Size HJ/7-10, 25mm thickness, Vitamin E UHMWPE |
00843575106285 | PS Tibial Insert, Size HJ/7-10, 22mm thickness, Vitamin E UHMWPE |
00843575106278 | PS Tibial Insert, Size FG/4-9, 25mm thickness, Vitamin E UHMWPE |
00843575106261 | PS Tibial Insert, Size FG/4-9, 22mm thickness, Vitamin E UHMWPE |
00843575106254 | PS Tibial Insert, Size DE/3-7, 25mm thickness, Vitamin E UHMWPE |
00843575106247 | PS Tibial Insert, Size DE/3-7, 22mm thickness, Vitamin E UHMWPE |
00843575106230 | PS Tibial Insert, Size BC/3-6, 25mm thickness, Vitamin E UHMWPE |
00843575106223 | PS Tibial Insert, Size BC/3-6, 22mm thickness, Vitamin E UHMWPE |
00843575106216 | PS Tibial Insert, Size A/1-4, 25mm thickness, Vitamin E UHMWPE |
00843575106209 | PS Tibial Insert, Size A/1-4, 22mm thickness , Vitamin E UHMWPE |
00843575106193 | Thick PS/PS PLUS Insert Trials Tray |
00843575106186 | PS Femoral 9-10; ARS Tray |
00843575106179 | PS Femoral Prep 3-8; ARS Tray |
00843575106162 | PS Femoral 1-2; ARS Tray |
00843575106155 | PS PLUS Insert Trials Tray |
00843575106148 | PS Insert Trials Tray |
00843575106131 | Tibial Preparation Tray |
00843575106124 | Tibial Resection Tray |
00843575106117 | PS Femoral Trials 3-8 Tray |
00843575106100 | PS Femoral 9-10; AR Tray |
00843575106094 | PS Femoral Prep 3-8; AR Tray |
00843575106087 | PS Femoral 1-2; AR Tray |
00843575106070 | PS Femoral 9-10; PR Tray |
00843575106063 | PS Femoral Prep 3-8; PR Tray |
00843575106056 | PS Femoral 1-2; PR Tray |
00843575106049 | Femoral Resection Tray |
00843575106032 | Patella Resection Tray |
00843575105974 | Pin Caddy |
00843575105967 | General Tray |
00843575105950 | Sterilization Tray Lid |
00843575105929 | Femoral Impactor |
00843575105912 | Tibial Baseplate Impactor |
00843575105905 | Tibial Insert Impactor |
00843575104779 | AR Sizer and Rotation Guide |
00843575104762 | PR Sizer and Rotation Guide |
00843575104755 | Patella Resection Stylus |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() MOBIO 88599336 not registered Live/Pending |
Exemplis LLC 2019-08-30 |
![]() MOBIO 87893417 5829749 Live/Registered |
B-ONE MEDICAL BIOTECH CORPORATION 2018-04-25 |
![]() MOBIO 86022210 not registered Dead/Abandoned |
Presonus Audio Electronics, Inc. 2013-07-29 |
![]() MOBIO 78302669 2893463 Dead/Cancelled |
Cryptolex, Inc. 2003-09-19 |
![]() MOBIO 77933595 not registered Dead/Abandoned |
Presonus Audio Electronics, Inc. 2010-02-11 |
![]() MOBIO 76010007 not registered Dead/Abandoned |
Montclair Group Limited 2000-03-27 |