FDA.reportPublic FDA data

MOBIO™ Total Knee System

Primary DI
00843575104588
Brand
MOBIO™ Total Knee System
Company
B-ONE ORTHO, CORP.
Model
8829006350
Catalog number
8829006350
Device description
Headed Pin, 35mm
Published
2019-05-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843575104588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843575104588008435751045888435751045880843575104588

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/instrument assembling deviceA non-sterile, noninvasive tool designed to support assembly of the component parts of an orthopaedic implant or surgical instrument during an orthopaedic surgical procedure, typically when component sizes are determined during the procedure [e.g., stem, neck, and head femoral components of a total hip arthroplasty (THA)]. It is available in one of a variety of forms (e.g., holder, clamp/press), however it is not a component of the final instrument/implant and is not a surgical screwdriver or wrench. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
081315444
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843575127143MOBIO™ Total Knee System882133110988213311092026-03-06
00843575127150MOBIO™ Total Knee System882133111088213311102026-03-06
00843575127167MOBIO™ Total Knee System882133111188213311112026-03-06
00843575127174MOBIO™ Total Knee System882133111388213311132026-03-06
00843575127181MOBIO™ Total Knee System882133111688213311162026-03-06
00843575127198MOBIO™ Total Knee System882133111988213311192026-03-06
00843575127204MOBIO™ Total Knee System882133112288213311222026-03-06
00843575127211MOBIO™ Total Knee System882133112588213311252026-03-06
00843575127228MOBIO™ Total Knee System882133130988213313092026-03-06
00843575127235MOBIO™ Total Knee System882133131088213313102026-03-06
00843575127242MOBIO™ Total Knee System882133131188213313112026-03-06
00843575127259MOBIO™ Total Knee System882133131388213313132026-03-06
00843575127266MOBIO™ Total Knee System882133131688213313162026-03-06
00843575127273MOBIO™ Total Knee System882133131988213313192026-03-06
00843575127280MOBIO™ Total Knee System882133132288213313222026-03-06
00843575127297MOBIO™ Total Knee System882133132588213313252026-03-06
00843575127303MOBIO™ Total Knee System882133150988213315092026-03-06
00843575127310MOBIO™ Total Knee System882133151088213315102026-03-06
00843575127327MOBIO™ Total Knee System882133151188213315112026-03-06
00843575127334MOBIO™ Total Knee System882133151388213315132026-03-06

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