FDA.reportPublic FDA data

MOBIO™ Total Knee System

Primary DI
00843575104700
Brand
MOBIO™ Total Knee System
Company
B-ONE ORTHO, CORP.
Model
8829017000
Catalog number
8829017000
Device description
Torque Knob
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
00843575104700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843575104700008435751047008435751047000843575104700

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

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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