FDA.reportPublic FDA data

MEGA SPINE SYSTEM

Primary DI
08809763501586
Brand
MEGA SPINE SYSTEM
Company
BK MEDITECH CO.,LTD.
Model
10080
Device description
Torque Limiting Wrench 3.0mm
Published
2023-06-23
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
08809763501586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809763501586088097635015868809763501586

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, 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, typically manual rotation of a bone screw or setscrew, whilst providing a torque-limiting function to ensure that the screw is not over tightened, during an orthopaedic procedure. The device is typically made of metal/synthetic material (e.g., polysulphone) and may have a T-shaped handle grip. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable 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

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Primary DI, Brand, Company table
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