FDA.reportPublic FDA data

MOBIO™ Total Knee System

Primary DI
00843575106421
Brand
MOBIO™ Total Knee System
Company
B-ONE ORTHO, CORP.
Model
8829201000
Catalog number
8829201000
Device description
EM Tibial Alignment Guide, Spiked Uprod, Standard
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
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843575106421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843575106421008435751064218435751064210843575106421

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
00843575106445MOBIO™ Total Knee System882133320988213332092026-05-29
00843575106452MOBIO™ Total Knee System882133321088213332102026-05-29
00843575106469MOBIO™ Total Knee System882133321188213332112026-05-29
00843575106476MOBIO™ Total Knee System882133321388213332132026-05-29
00843575106483MOBIO™ Total Knee System882133321688213332162026-05-29
00843575106490MOBIO™ Total Knee System882133321988213332192026-05-29
00843575106506MOBIO™ Total Knee System882133322288213332222026-05-29
00843575106513MOBIO™ Total Knee System882133322588213332252026-05-29
00843575106520MOBIO™ Total Knee System882134320988213432092026-05-29
00843575106537MOBIO™ Total Knee System882134321088213432102026-05-29
00843575106544MOBIO™ Total Knee System882134321188213432112026-05-29
00843575106551MOBIO™ Total Knee System882134321388213432132026-05-29
00843575106568MOBIO™ Total Knee System882134321688213432162026-05-29
00843575106575MOBIO™ Total Knee System882134321988213432192026-05-29
00843575106582MOBIO™ Total Knee System882134322288213432222026-05-29
00843575106599MOBIO™ Total Knee System882134322588213432252026-05-29
00843575107619MOBIO™ Total Knee System882930200988293020092026-05-29
00843575107626MOBIO™ Total Knee System882930201088293020102026-05-29
00843575107633MOBIO™ Total Knee System882930201188293020112026-05-29
00843575107640MOBIO™ Total Knee System882930201388293020132026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982350596VOLTSynthes GmbHHWT2026-09-25
10886982350602VOLTSynthes GmbHHWT2026-09-25
10886982350619VOLTSynthes GmbHHWT2026-09-25
10886982350626VOLTSynthes GmbHHWT2026-09-25
10886982350695VOLTSynthes GmbHHWT2026-09-25
10886982350701VOLTSynthes GmbHHWT2026-09-25
10886982350718VOLTSynthes GmbHHWT2026-09-25
00840606191326PrimusSPINAL ELEMENTS, INC.HWT2026-09-22
03701313009502K-RODS.M.A.I.OHWT2026-09-22
10888857298590ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298606ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298613ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298620ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298637ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298644ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298651ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298668ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298675ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298682ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298699ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298705ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298712ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298729ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857562332K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562349K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562356K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562363K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562370K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562387K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562394K2M General InstrumentsVB Spine LLCHWT2023-09-08