FDA.reportPublic FDA data

MEGA SPINE SYSTEM

Primary DI
08809763500251
Brand
MEGA SPINE SYSTEM
Company
BK MEDITECH CO.,LTD.
Model
51635
Device description
T-Wrench 3.0mm
Published
2023-06-14
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
HXCWrench

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXCWrenchOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809763500251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809763500251088097635002518809763500251

GMDN Terms#

Term, Definition table
TermDefinition
Surgical torque wrench, reusableA hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982362964NASynthes GmbHHXC2026-05-04
08059386742273Orthopaedic Surgical InstrumentsCITIEFFE SRLHXC2025-11-05
1085007050056915mm CurvaFix Hex Wrench CURVAFIX, INC.HXC2025-10-22
10889981437794SpecialsSeaspine Orthopedics CorporationHXC2025-10-17
18059015376494ORTHOFIXORTHOFIX SRLHXC2025-03-31
18059015376029TRUELOK SYSTEMORTHOFIX SRLHXC2025-01-10
10840199540805Modified Kaufman Type Kidney ClampKOROS U.S.A., INC.HXC2024-01-31
08800068966230LOSPA Modular Knee SystemCorentec Co., LtdHXC2022-10-24
08800068964960LOSPA Modular Knee System Corentec Co., LtdHXC2022-10-23
10845854023976ULTRAPOWERConmed CorporationHXC2022-06-02
B07301K0360280Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380000Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380010Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380020Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380030Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380200Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380220Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380240Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380260Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380300Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380420Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380600Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380820Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380830Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380840Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380850Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0381200Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0381220Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
10886982195722NASynthes GmbHHXC2019-02-21
08809265159063Surgical InstrumentJeil Medical CorporationHXC2018-11-28