FDA.reportPublic FDA data

4CIS VANE SPINE SYSTEM

Primary DI
08806373521911
Brand
4CIS VANE SPINE SYSTEM
Company
ALPHANOX CO.,LTD.
Model
4031-6545
Catalog number
4031-6545
Device description
Mono Axial Pedicle Screw, 6.5x45mm
Published
2016-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121615000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1216150004CIS VANE SPINE SYSTEMSolco Biomedical Co., Ltd.2012-08-15MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806373521911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806373521911088063735219118806373521911

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
687844241
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
088063735215224CIS VANE SPINE SYSTEM4002-55354002-55352015-09-24
088063735215394CIS VANE SPINE SYSTEM4002-55404002-55402015-09-24
088063735215464CIS VANE SPINE SYSTEM4002-55454002-55452015-09-24
088063735215534CIS VANE SPINE SYSTEM4002-65354002-65352015-09-24
088063735215604CIS VANE SPINE SYSTEM4002-65404002-65402015-09-24
088063735215774CIS VANE SPINE SYSTEM4002-65454002-65452015-09-24
088063735215844CIS VANE SPINE SYSTEM4002-65504002-65502015-09-24
088063735215914CIS VANE SPINE SYSTEM4002-75354002-75352015-09-24
088063735216074CIS VANE SPINE SYSTEM4002-75404002-75402015-09-24
088063735216144CIS VANE SPINE SYSTEM4002-75454002-75452015-09-24
088063735216214CIS VANE SPINE SYSTEM4002-85354002-85352015-09-24
088063735216384CIS VANE SPINE SYSTEM4002-85404002-85402015-09-24
088063735216454CIS VANE SPINE SYSTEM4002-85454002-85452015-09-24
088063735216524CIS VANE SPINE SYSTEM4002-85504002-85502015-09-24
088063735217064CIS VANE SPINE SYSTEM4012-55304012-55302015-09-24
088063735217134CIS VANE SPINE SYSTEM4012-55354012-55352015-09-24
088063735217204CIS VANE SPINE SYSTEM4012-55404012-55402015-09-24
088063735217374CIS VANE SPINE SYSTEM4012-55454012-55452015-09-24
088063735217444CIS VANE SPINE SYSTEM4012-65354012-65352015-09-24
088063735217514CIS VANE SPINE SYSTEM4012-65404012-65402015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806364689439Kora Spinal SystemMedyssey Co., Ltd.MNH2026-10-01
08806364690077Kora Spinal SystemMedyssey Co., Ltd.MNH2026-10-01
10888857001428DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001497DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001527DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001589DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001619DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001640DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001725DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001763DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001787DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001824DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001848DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001923DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001947DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001978DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001992DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857002036DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857002050DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857002074DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857002098DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857002111DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857002135DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24