GII

GUDID 07640173165187

flexStaas poly axial screw

coLigne AG

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 07640173165187
• NIH Device Record Key: 8ac5b8a9-371b-4323-abae-88f530249f5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GII
• Version Model Number: 83.535
• Company DUNS: 482467792
• Company Name: coLigne AG
• 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: false
• Expiration Date: true
• 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: +41433438000
• Email: info@coligne.com
• Phone: +41433438000
• Email: info@coligne.com
• Phone: +41433438000
• Email: info@coligne.com
• Phone: +41433438000
• Email: info@coligne.com
• Phone: +41433438000
• Email: info@coligne.com
• Phone: +41433438000
• Email: info@coligne.com
• Phone: +41433438000
• Email: info@coligne.com
• Phone: +41433438000
• Email: info@coligne.com
• Phone: +41433438000
• Email: info@coligne.com
• Phone: +41433438000
• Email: info@coligne.com
• Phone: +41433438000
• Email: info@coligne.com
• Phone: +41433438000
• Email: info@coligne.com
• Phone: +41433438000
• Email: info@coligne.com
• Phone: +41433438000
• Email: info@coligne.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640173165187 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210306

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[07640173165187]

Moist Heat or Steam Sterilization

[07640173165187]

Moist Heat or Steam Sterilization

[07640173165187]

Moist Heat or Steam Sterilization

[07640173165187]

Moist Heat or Steam Sterilization

[07640173165187]

Moist Heat or Steam Sterilization

[07640173165187]

Moist Heat or Steam Sterilization

[07640173165187]

Moist Heat or Steam Sterilization

[07640173165187]

Moist Heat or Steam Sterilization

[07640173165187]

Moist Heat or Steam Sterilization

[07640173165187]

Moist Heat or Steam Sterilization

[07640173165187]

Moist Heat or Steam Sterilization

[07640173165187]

Moist Heat or Steam Sterilization

[07640173165187]

Moist Heat or Steam Sterilization

[07640173165187]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-09
• Device Publish Date: 2021-07-01

On-Brand Devices [GII]

• 07640173166177: titanium screw
• 07640173165613: clip connector
• 07640173165552: set screw, saw threaded
• 07640173165545: poly axial reduction screw
• 07640173165538: poly axial reduction screw
• 07640173165521: poly axial reduction screw
• 07640173165514: poly axial reduction screw
• 07640173165507: poly axial reduction screw
• 07640173165491: poly axial reduction screw
• 07640173165484: poly axial reduction screw
• 07640173165477: poly axial reduction screw
• 07640173165460: poly axial reduction screw
• 07640173165453: poly axial reduction screw
• 07640173165446: poly axial reduction screw
• 07640173165439: poly axial reduction screw
• 07640173165163: poly axial screw 78-series
• 07640173165156: poly axial screw 78-series
• 07640173165149: poly axial screw 78-series
• 07640173165132: poly axial screw 78-series
• 07640173165125: poly axial screw 78-series
• 07640173165118: poly axial screw 78-series
• 07640173165101: poly axial screw 78-series
• 07640173165095: poly axial screw 78-series
• 07640173165088: poly axial screw 78-series
• 07640173165071: poly axial screw 78-series
• 07640173165064: poly axial screw 78-series
• 07640173165057: poly axial screw 78-series
• 07640173165040: poly axial screw 78-series
• 07640173165033: poly axial screw 78-series
• 07640173165026: poly axial screw 78-series
• 07640173165019: poly axial screw 78-series
• 07640173165002: poly axial screw 78-series
• 07640173164999: poly axial screw 78-series
• 07640173164982: poly axial screw 78-series
• 07640173164975: poly axial screw 78-series
• 07640173164968: poly axial screw 78-series
• 07640173164951: poly axial screw 78-series
• 07640173164944: poly axial screw 78-series
• 07640173164937: poly axial screw 78-series
• 07640173164920: poly axial screw 78-series
• 07640173164913: poly axial screw 78-series
• 07640173164906: poly axial screw 78-series
• 07640173164890: poly axial screw 78-series
• 07640173164807: mono axial screw
• 07640173164791: mono axial screw
• 07640173164784: mono axial screw
• 07640173164777: mono axial screw
• 07640173164760: mono axial screw
• 07640173164753: mono axial screw
• 07640173164746: mono axial screw