FDA.reportPublic FDA data

Vertefix

Primary DI
06009696221151
Brand
Vertefix
Company
ELITE SURGICAL SUPPLIES (PTY) LTD
Model
SP6550T
Catalog number
SP6550T
Device description
Mono Axial Pedicle Screw 6.5x50mm
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06009696221151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009696221151060096962211516009696221151

GMDN Terms#

Term, Definition table
TermDefinition
Trans-facet-screw internal spinal fixation system, sterileA sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
568359710
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06009696221076VertefixSP5535TSP5535T2016-09-22
06009696221083VertefixSP5540TSP5540T2016-09-23
06009696221090VertefixSP5545TSP5545T2016-09-23
06009696221106VertefixSP5550TSP5550T2016-09-23
06009696221120VertefixSP6535TSP6535T2016-09-23
06009696221137VertefixSP6540TSP6540T2016-09-23
06009696221144VertefixSP6545TSP6545T2016-09-23
06009696221175VertefixSP7535TSP7535T2016-09-23
06009696221182VertefixSP7540TSP7540T2016-09-23
06009696221199VertefixSP7545TSP7545T2016-09-23
06009696221205VertefixSP7550TSP7550T2016-09-23
06009696221229VertefixMA5535TMA5535T2016-09-23
06009696221236VertefixMA5540TMA5540T2016-09-23
06009696221243VertefixMA5545TMA5545T2016-09-23
06009696221250VertefixMA5550TMA5550T2016-09-23
06009696221274VertefixMA6535TMA6535T2016-09-23
06009696221281VertefixMA6540TMA6540T2016-09-23
06009696221298VertefixMA6545TMA6545T2016-09-23
06009696221304VertefixMA6550TMA6550T2016-09-23
06009696221328VertefixMA7535TMA7535T2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857037953EVEREST® Spinal SystemVB Spine LLCMNH2026-06-11
10888857037953EVEREST® Spinal SystemVB Spine LLCMNI2026-06-11
10888857037977EVEREST® Spinal SystemVB Spine LLCMNI2026-06-11
10888857037977EVEREST® Spinal SystemVB Spine LLCMNH2026-06-11
10888857001428DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001428DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857008724EVEREST® Spinal SystemVB Spine LLCMNI2016-03-10
10888857008724EVEREST® Spinal SystemVB Spine LLCMNH2016-03-10
10888857001497DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24
10888857001497DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001527DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001527DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24
10888857001589DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001589DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24
10888857001619DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24
10888857001619DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24