Auxein Brand Vertaux 5.5 mm Pedicle Screw System

GUDID 08903993310397

VERTAUX - Monoaxial Pedicle Screw with Cap, Ø7.0mm x Length 50mm, Titanium

Auxein Medical Private Limited

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08903993310397
• NIH Device Record Key: 258ac808-4e59-4c3b-a0ef-0ce7c4b160d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Auxein Brand Vertaux 5.5 mm Pedicle Screw System
• Version Model Number: SP-229
• Company DUNS: 872194615
• Company Name: Auxein Medical Private Limited
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: +919910643638
• Email: info@auxein.com
• Phone: +919910643638
• Email: info@auxein.com
• Phone: +919910643638
• Email: info@auxein.com
• Phone: +919910643638
• Email: info@auxein.com
• Phone: +919910643638
• Email: info@auxein.com
• Phone: +919910643638
• Email: info@auxein.com
• Phone: +919910643638
• Email: info@auxein.com
• Phone: +919910643638
• Email: info@auxein.com
• Phone: +919910643638
• Email: info@auxein.com
• Phone: +919910643638
• Email: info@auxein.com
• Phone: +919910643638
• Email: info@auxein.com
• Phone: +919910643638
• Email: info@auxein.com
• Phone: +919910643638
• Email: info@auxein.com
• Phone: +919910643638
• Email: info@auxein.com
• Phone: +919910643638
• Email: info@auxein.com
• Phone: +919910643638
• Email: info@auxein.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08903993310397 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201457

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[08903993310397]

Moist Heat or Steam Sterilization

[08903993310397]

Moist Heat or Steam Sterilization

[08903993310397]

Moist Heat or Steam Sterilization

[08903993310397]

Moist Heat or Steam Sterilization

[08903993310397]

Moist Heat or Steam Sterilization

[08903993310397]

Moist Heat or Steam Sterilization

[08903993310397]

Moist Heat or Steam Sterilization

[08903993310397]

Moist Heat or Steam Sterilization

[08903993310397]

Moist Heat or Steam Sterilization

[08903993310397]

Moist Heat or Steam Sterilization

[08903993310397]

Moist Heat or Steam Sterilization

[08903993310397]

Moist Heat or Steam Sterilization

[08903993310397]

Moist Heat or Steam Sterilization

[08903993310397]

Moist Heat or Steam Sterilization

[08903993310397]

Moist Heat or Steam Sterilization

[08903993310397]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-15
• Device Publish Date: 2021-07-07

On-Brand Devices [Auxein Brand Vertaux 5.5 mm Pedicle Screw System]

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• 08903993401439: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø7.0mm x Length 25mm, Titanium
• 08903993401422: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.5mm x Length 25mm, Titanium
• 08903993401415: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.0mm x Length 25mm, Titanium
• 08903993401408: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.5mm x Length 25mm, Titanium
• 08903993401392: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.0mm x Length 25mm, Titanium
• 08903993401385: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø4.5mm x Length 25mm, Titanium
• 08903993394427: VERTAUX - Polyaxial Pedicle Screw with Cap, Ø5.0mm x Length 30mm, Titanium
• 08903993394410: VERTAUX - Polyaxial Pedicle Screw with Cap, Ø4.5mm x Length 45mm, Titanium
• 08903993391518: VERTAUX - Polyaxial Pedicle Screw with Cap, Ø4.5mm x Length 30mm, Titanium
• 08903993389454: VERTAUX - Polyaxial Pedicle Screw with Cap, Ø5.0mm x Length 55mm, Titanium
• 08903993389447: VERTAUX - Polyaxial Pedicle Screw with Cap, Ø5.0mm x Length 50mm, Titanium
• 08903993389430: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø7.0mm x Length 30mm, Titanium
• 08903993389423: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.5mm x Length 30mm, Titanium
• 08903993389416: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.0mm x Length 30mm, Titanium
• 08903993389409: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.5mm x Length 55mm, Titanium
• 08903993389393: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.5mm x Length 30mm, Titanium
• 08903993389386: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.0mm x Length 55mm, Titanium
• 08903993389379: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.0mm x Length 50mm, Titanium
• 08903993389362: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.0mm x Length 30mm, Titanium
• 08903993389355: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø4.5mm x Length 50mm, Titanium
• 08903993389348: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø4.5mm x Length 45mm, Titanium
• 08903993389331: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø4.5mm x Length 30mm, Titanium
• 08903993389294: VERTAUX - Polyaxial Pedicle Screw with Cap, Ø4.5mm x Length 50mm, Titanium
• 08903993355817: VERTAUX - Polyaxial Pedicle Screw with Cap, Ø4.5mm x Length 25mm, Titanium
• 08903993310694: VERTAUX - Polyaxial Pedicle Screw with Cap, Ø5.0mm x Length 45mm, Titanium
• 08903993310687: VERTAUX - Polyaxial Pedicle Screw with Cap, Ø5.0mm x Length 40mm, Titanium
• 08903993310670: VERTAUX - Polyaxial Pedicle Screw with Cap, Ø5.0mm x Length 35mm, Titanium
• 08903993310663: VERTAUX - Polyaxial Pedicle Screw with Cap, Ø4.5mm x Length 40mm, Titanium
• 08903993310656: VERTAUX - Polyaxial Pedicle Screw with Cap, Ø4.5mm x Length 35mm, Titanium
• 08903993310403: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø7.0mm x Length 55mm, Titanium
• 08903993310397: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø7.0mm x Length 50mm, Titanium
• 08903993310380: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø7.0mm x Length 45mm, Titanium
• 08903993310373: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø7.0mm x Length 40mm, Titanium
• 08903993310359: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.5mm x Length 55mm, Titanium
• 08903993310342: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.5mm x Length 50mm, Titanium
• 08903993310335: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.5mm x Length 45mm, Titanium
• 08903993310328: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.5mm x Length 40mm, Titanium
• 08903993310311: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.5mm x Length 35mm, Titanium
• 08903993310304: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.0mm x Length 55mm, Titanium
• 08903993310298: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.0mm x Length 50mm, Titanium
• 08903993310281: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.0mm x Length 45mm, Titanium
• 08903993310274: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.0mm x Length 40mm, Titanium
• 08903993310267: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø6.0mm x Length 35mm, Titanium
• 08903993310250: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.5mm x Length 50mm, Titanium
• 08903993310243: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.5mm x Length 45mm, Titanium
• 08903993310236: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.5mm x Length 40mm, Titanium
• 08903993310229: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.5mm x Length 35mm, Titanium
• 08903993310212: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.0mm x Length 45mm, Titanium
• 08903993310205: VERTAUX - Monoaxial Pedicle Screw with Cap, Ø5.0mm x Length 40mm, Titanium