FDA.reportPublic FDA data

MEGA PLUS MIS SPINE SYSTEM

Primary DI
08809763502804
Brand
MEGA PLUS MIS SPINE SYSTEM
Company
BK MEDITECH CO.,LTD.
Model
14245
Device description
Guide Wire(Nitinol)
Published
2023-06-14
Public version status
Update
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
08809763502804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809763502804088097635028048809763502804

GMDN Terms#

Term, Definition table
TermDefinition
Spinal procedural guidewireA flexible wire intended to facilitate percutaneous introduction of interventional (non-implantable) surgical devices (e.g., cannula) during spinal surgery. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
687941818
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809763504518INNESIS PEEK CAGE52719-102023-06-23
08809763504686INNESIS PEEK CAGE52790-102023-06-23
08809763504754INNESIS PEEK TL CAGE52810-102023-06-23
08809763504778INNESIS PEEK TL CAGE529302023-06-23
08809763504785INNESIS PEEK TL CAGE52820-102023-06-23
08809763504792INNESIS PEEK TL CAGE52825-102023-06-23
08809763504808INNESIS PEEK CERVICAL CAGE42620-102023-06-23
08809763504280INNESIS PEEK CAGE527192023-06-14
08809763504297INNESIS PEEK CAGE52740-202023-06-14
08809763504389INNESIS PEEK CAGE527902023-06-14
08809763504396INNESIS PEEK CERVICAL CAGE426102023-06-14
08809763504402INNESIS PEEK CERVICAL CAGE426202023-06-14
08809763504419INNESIS PEEK CERVICAL CAGE426302023-06-14
08809763504457INNESIS PEEK TL CAGE528102023-06-14
08809763504464INNESIS PEEK TL CAGE528202023-06-14
08809763504471INNESIS PEEK TL CAGE528252023-06-14
08809763504488INNESIS PEEK TL CAGE528602023-06-14
08809763504693INNESIS PEEK CERVICAL CAGE42610-202023-06-14
08809763504709INNESIS PEEK CERVICAL CAGE42610-102023-06-14
08809763500534MEGA SPINE SYSTEM51710-102023-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867550292Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550308Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550315Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550322Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550339Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550346Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550353Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550360Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550377Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550384Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552692Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552708Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552715Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552722Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552739Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552746Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552753Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552760Arthrex®ARTHREX, INC.LXH2026-09-18
00888867574564Arthrex®ARTHREX, INC.LXH2026-09-18
00888867574571Arthrex®ARTHREX, INC.LXH2026-09-18
00888867574588Arthrex®ARTHREX, INC.LXH2026-09-18
04054896000831Control GaugesSilony Medical GmbHLXH2026-09-18
04054896000855Implant ModifierSilony Medical GmbHLXH2026-09-18
04054896000862Implant ModifierSilony Medical GmbHLXH2026-09-18
04054896000879Implant ModifierSilony Medical GmbHLXH2026-09-18
04054896000886Forceps and ClampsSilony Medical GmbHLXH2026-09-18
04054896000893(Re-) Positioning ToolsSilony Medical GmbHLXH2026-09-18
04054896000909(Re-) Positioning ToolsSilony Medical GmbHLXH2026-09-18
04054896000916(Re-) Positioning ToolsSilony Medical GmbHLXH2026-09-18
04054896000923AdapterSilony Medical GmbHLXH2026-09-18