FDA.reportPublic FDA data

DVX SPINE SYSTEM

Primary DI
08809155852289
Brand
DVX SPINE SYSTEM
Company
BK MEDITECH CO.,LTD.
Model
81110
Device description
Locking Cap
Published
2015-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080876000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080876000DVX SPINE SYSTEMBk Meditech, Co., Ltd.2008-06-04MNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809155852289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809155852289088091558522898809155852289

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone set screwA small, threaded, implantable, non-bioabsorbable disc intended to be threaded into the proximal end of a spinal bone screw (screw head), anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
687941818
Device count
1
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
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-06-28
10889981065348MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065348MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065539MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065539MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065553MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065553MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065577MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065577MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065584MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065584MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065607MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065607MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065645MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065645MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065669MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065669MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981005115NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005115NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005139NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005139NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005146NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005146NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005290NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005290NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005306NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005306NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005313NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005313NewportSeaspine Orthopedics CorporationMNI2015-09-24