FDA.reportPublic FDA data

Vertefix

Primary DI
06009696221083
Brand
Vertefix
Company
ELITE SURGICAL SUPPLIES (PTY) LTD
Model
SP5540T
Catalog number
SP5540T
Device description
Mono Axial Pedicle Screw 5.5x40mm Titanium
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
06009696221083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009696221083060096962210836009696221083

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
06009696221090VertefixSP5545TSP5545T2016-09-23
06009696221106VertefixSP5550TSP5550T2016-09-23
06009696221120VertefixSP6535TSP6535T2016-09-23
06009696221137VertefixSP6540TSP6540T2016-09-23
06009696221144VertefixSP6545TSP6545T2016-09-23
06009696221151VertefixSP6550TSP6550T2016-09-23
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
00840311244874Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311244874Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311244881Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311244881Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311244904Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311244904Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311244928Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311244928Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311244935Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311244935Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311244942Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311244942Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245017Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245017Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245024Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245024Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245062Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245062Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245079Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245079Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245130Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245130Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245154Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245154Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245161Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245161Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245185Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245185Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245208Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311245208Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03