VERTEFIX CZ7550CT

GUDID 06009708426178

MULTI AXIAL PEDICLE SCREW 7.5 X 50

ELITE SURGICAL SUPPLIES (PTY) LTD

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 06009708426178
• NIH Device Record Key: edf08182-d2e7-4b75-a3fa-dba709f9f50f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERTEFIX
• Version Model Number: CZ7550CT
• Catalog Number: CZ7550CT
• Company DUNS: 568359710
• Company Name: ELITE SURGICAL SUPPLIES (PTY) LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +27123860012
• Email: info@elitesurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06009708426178 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080075

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[06009708426178]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-03
• Device Publish Date: 2020-01-24

On-Brand Devices [VERTEFIX]

• 06009696221908: Cross Linking assembly device
• 06009696221885: Alignment Rod Titanium 5.0x300mm
• 06009696221878: Alignment Rod Titanium 5.0x200mm
• 06009696221861: Alignment Rod Titanium 5.0x150mm
• 06009696221854: Alignment Rod 5.0x125mm
• 06009696221847: Alignment Rod Titanium 5.0x100mm
• 06009696221830: Alignment Rod Titanium 5.0x75mm
• 06009696221823: Alignment Rod Titanium 5.0x50mm
• 06009696221458: Multi Axial Extension Pedicle Screw 6.5x50mm
• 06009696221441: Multi Axial Extension Pedicle Screw 6.5x45mm
• 06009696221434: Multi Axial Extension Pedicle Screw 6.5x40mm
• 06009696221427: Multi Axial Extension Pedicle Screw 6.5x35mm Titanium
• 06009696221403: Multi Axial Pedicle Screw 8.5x50mm
• 06009696221397: Multi Axial Pedicle Screw 8.5x45mm
• 06009696221380: Multi Axial Pedicle Screw 8.5x40mm Titanium
• 06009696221373: Multi Axial Pedicle Screw 8.5x35mm
• 06009696221359: Multi Axial Pedicle Screw 7.5x50mm
• 06009696221342: Multi Axial Pedicle Screw 7.5x45mm
• 06009696221335: Multi Axial Pedicle Screw 7.5x40mm
• 06009696221328: Multi Axial Pedicle Screw 7.5x35mm
• 06009696221304: Multi Axial Pedicle Screw 6.5x50mm Titanium
• 06009696221298: Multi Axial Pedicle Screw 6.5x45mm
• 06009696221281: Multi Axial Pedicle Screw 6.5x40mm
• 06009696221274: Multi Axial Pedicle Screw 6.5x35mm
• 06009696221250: Multi Axial Pedicle Screw 5.5x50mm Titanium
• 06009696221243: Multi Axial Pedicle Screw 5.5x45mm
• 06009696221236: Multi Axial Pedicle Screw 5.5x40mm
• 06009696221229: Multi Axial Pedicle Screw 5.5x35mm Titanium
• 06009696221205: Mono Axial Pedicle Screw 7.5x50mm Titanium
• 06009696221199: Mono Axial Pedicle Screw 7.5x45mm Titanium
• 06009696221182: Mono Axial Pedicle Screw 7.5x40mm Titanium
• 06009696221175: Mono Axial Pedicle Screw 7.5x35mm Titanium
• 06009696221151: Mono Axial Pedicle Screw 6.5x50mm
• 06009696221144: Mono Axial Pedicle Screw 6.5x45mm
• 06009696221137: Mono Axial Pedicle Screw 6.5x40mm
• 06009696221120: Mono Axial Pedicle Screw 6.5x35mm
• 06009696221106: Mono Axial Pedicle Screw 5.5x50mm Titanium
• 06009696221090: Mono Axial Pedicle Screw 5.5x45mm Tianium.
• 06009696221083: Mono Axial Pedicle Screw 5.5x40mm Titanium
• 06009696221076: Mono Axial Pedicle Screw 5.5x35mm.
• 06009708426222: MULTI AXIAL PEDICLE SCREW 8.5 X 50
• 06009708426215: MULTI AXIAL PEDICLE SCREW 8.5 X 45
• 06009708426208: MULTI AXIAL PEDICLE SCREW 8.5 X 40
• 06009708426192: MULTI AXIAL PEDICLE SCREW 8.5 X 35
• 06009708426185: MULTI AXIAL PEDICLE SCREW 7.5 X 55
• 06009708426178: MULTI AXIAL PEDICLE SCREW 7.5 X 50
• 06009708426161: MULTI AXIAL PEDICLE SCREW 7.5 X 45
• 06009708426154: MULTI AXIAL PEDICLE SCREW 7.5 X 40
• 06009708426147: MULTI AXIAL PEDICLE SCREW 7.5 X 35
• 06009708426130: MULTI AXIAL PEDICLE SCREW 7.5 X 30