MOBIO™ Total Knee System 8821321009

GUDID 00843575108074

CR Tibial Insert, Standard UHMWPE, Size A/1-4, 9 mm

B-ONE ORTHO, CORP.

Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis Cruciate-retaining total knee prosthesis
Primary Device ID00843575108074
NIH Device Record Key99abe263-0ccc-4242-b77c-80c1c7dbfb3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMOBIO™ Total Knee System
Version Model Number8821321009
Catalog Number8821321009
Company DUNS081315444
Company NameB-ONE ORTHO, CORP.
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100843575108074 [Primary]

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-10
Device Publish Date2021-06-02

On-Brand Devices [MOBIO™ Total Knee System]

00843575106438EM Tibial Alignment Guide, Non-Spiked Uprod, Standard
00843575106421EM Tibial Alignment Guide, Spiked Uprod, Standard
00843575106414PS+ Tibial Insert, Size HJ/7-10+, 25mm thickness, Vitamin E UHMWPE
00843575106407PS+ Tibial Insert, Size HJ/7-10+, 22mm thickness, Vitamin E UHMWPE
00843575106391PS+ Tibial Insert, Size FG/4-9+, 25mm thickness, Vitamin E UHMWPE
00843575106384PS+ Tibial Insert, Size FG/4-9+, 22mm thickness, Vitamin E UHMWPE
00843575106377PS+ Tibial Insert, Size DE/3-7+, 25mm thickness, Vitamin E UHMWPE
00843575106360PS+ Tibial Insert, Size DE/3-7+, 22mm thickness, Vitamin E UHMWPE
00843575106353PS+ Tibial Insert, Size BC/3-6+, 25mm thickness, Vitamin E UHMWPE
00843575106346PS+ Tibial Insert, Size BC/3-6+, 22mm thickness, Vitamin E UHMWPE
00843575106339PS+ Tibial Insert, Size A/3-4+, 25mm thickness, Vitamin E UHMWPE
00843575106322PS+ Tibial Insert, Size A/3-4+, 22mm thickness, Vitamin E UHMWPE
00843575106315PS+ Tibial Insert, Size A/1-2+, 25mm thickness, Vitamin E UHMWPE
00843575106308PS+ Tibial Insert, Size A/1-2+, 22mm thickness, Vitamin E UHMWPE
00843575106292PS Tibial Insert, Size HJ/7-10, 25mm thickness, Vitamin E UHMWPE
00843575106285PS Tibial Insert, Size HJ/7-10, 22mm thickness, Vitamin E UHMWPE
00843575106278PS Tibial Insert, Size FG/4-9, 25mm thickness, Vitamin E UHMWPE
00843575106261PS Tibial Insert, Size FG/4-9, 22mm thickness, Vitamin E UHMWPE
00843575106254PS Tibial Insert, Size DE/3-7, 25mm thickness, Vitamin E UHMWPE
00843575106247PS Tibial Insert, Size DE/3-7, 22mm thickness, Vitamin E UHMWPE
00843575106230PS Tibial Insert, Size BC/3-6, 25mm thickness, Vitamin E UHMWPE
00843575106223PS Tibial Insert, Size BC/3-6, 22mm thickness, Vitamin E UHMWPE
00843575106216PS Tibial Insert, Size A/1-4, 25mm thickness, Vitamin E UHMWPE
00843575106209PS Tibial Insert, Size A/1-4, 22mm thickness , Vitamin E UHMWPE
00843575106193Thick PS/PS PLUS Insert Trials Tray
00843575106186PS Femoral 9-10; ARS Tray
00843575106179PS Femoral Prep 3-8; ARS Tray
00843575106162PS Femoral 1-2; ARS Tray
00843575106155PS PLUS Insert Trials Tray
00843575106148PS Insert Trials Tray
00843575106131Tibial Preparation Tray
00843575106124Tibial Resection Tray
00843575106117PS Femoral Trials 3-8 Tray
00843575106100PS Femoral 9-10; AR Tray
00843575106094PS Femoral Prep 3-8; AR Tray
00843575106087PS Femoral 1-2; AR Tray
00843575106070PS Femoral 9-10; PR Tray
00843575106063PS Femoral Prep 3-8; PR Tray
00843575106056PS Femoral 1-2; PR Tray
00843575106049Femoral Resection Tray
00843575106032Patella Resection Tray
00843575105974Pin Caddy
00843575105967General Tray
00843575105950Sterilization Tray Lid
00843575105929Femoral Impactor
00843575105912Tibial Baseplate Impactor
00843575105905Tibial Insert Impactor
00843575104779AR Sizer and Rotation Guide
00843575104762PR Sizer and Rotation Guide
00843575104755Patella Resection Stylus

Trademark Results [MOBIO]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MOBIO
MOBIO
88599336 not registered Live/Pending
Exemplis LLC
2019-08-30
MOBIO
MOBIO
87893417 5829749 Live/Registered
B-ONE MEDICAL BIOTECH CORPORATION
2018-04-25
MOBIO
MOBIO
86022210 not registered Dead/Abandoned
Presonus Audio Electronics, Inc.
2013-07-29
MOBIO
MOBIO
78302669 2893463 Dead/Cancelled
Cryptolex, Inc.
2003-09-19
MOBIO
MOBIO
77933595 not registered Dead/Abandoned
Presonus Audio Electronics, Inc.
2010-02-11
MOBIO
MOBIO
76010007 not registered Dead/Abandoned
Montclair Group Limited
2000-03-27

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