FDA.reportPublic FDA data

VERTEFIX

Primary DI
06009708426109
Brand
VERTEFIX
Company
ELITE SURGICAL SUPPLIES (PTY) LTD
Model
CZ6545CT
Catalog number
CZ6545CT
Device description
MULTI AXIAL PEDICLE SCREW 6.5 X 45
Published
2020-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080075000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080075000MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEMElite Surgical Supplies (Pty), Ltd.2008-01-28MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06009708426109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009708426109060097084261096009708426109

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

Contacts#

Phone, Email table
PhoneEmail
+27123860012info@elitesurgical.com

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04047844129418DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129425DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129425DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129432DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129432DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129449DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129449DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129456DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129456DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129463DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129463DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129470DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129470DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129487DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129487DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129494DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129494DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129500DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129500DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129517DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129517DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129524DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129524DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129531DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129531DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129548DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129548DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129555DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129555DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13