FDA.reportPublic FDA data

MEGA SPINE SYSTEM

Primary DI
08809763500718
Brand
MEGA SPINE SYSTEM
Company
BK MEDITECH CO.,LTD.
Model
81645-40
Device description
Bent Probe
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
HXBProbe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXBProbeOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809763500718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809763500718088097635007188809763500718

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal/ENT/orthopaedic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. 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
04052536085507neon3Ulrich GmbH & Co. KGHXB2026-05-28
07640221373045PERLA ® TLSpineArt SAHXB2026-05-07
08800017271095ProbeCorentec Co., LtdHXB2026-04-10
10649111181665Sklar InstrumentsSKLAR CORPORATIONHXB2025-05-29
07640177820631Neo Medical Pedicle Screw SystemNeo Medical SAHXB2023-01-26
07898506815241QuinelatoSchobell Industrial LtdaHXB2023-01-09
07899798204461SchobellSchobell Industrial LtdaHXB2022-12-16
G079C5020010040Golden Isles Pedicle Screw SystemIntelivation, LLCHXB2022-10-26
10649111296673SklarSKLAR CORPORATIONHXB2019-03-19
10649111296932SklarSKLAR CORPORATIONHXB2019-03-19
10649111297120SklarSKLAR CORPORATIONHXB2019-03-19
10649111297496SklarSKLAR CORPORATIONHXB2019-03-19
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10649111176982Sklar®SKLAR CORPORATIONHXB2019-01-24
10649111151477Sklar®SKLAR CORPORATIONHXB2018-11-20
10649111153983Sklar®SKLAR CORPORATIONHXB2018-11-20
10649111155208Sklar®SKLAR CORPORATIONHXB2018-11-20
10649111156847Sklar®SKLAR CORPORATIONHXB2018-11-20
10649111220524Sklar®SKLAR CORPORATIONHXB2018-11-08
10649111220739Sklar®SKLAR CORPORATIONHXB2018-11-08
10649111083389Sklar®SKLAR CORPORATIONHXB2018-10-24
10649111013881Sklar®SKLAR CORPORATIONHXB2018-09-14
10649111018688Sklar®SKLAR CORPORATIONHXB2018-09-14