GII

GUDID 07640173163664

ostaPek plate

coLigne AG

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 07640173163664
• NIH Device Record Key: 623b4ad2-36e1-4ebb-97de-1f6774a82102
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GII
• Version Model Number: 43.019
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +41433438000
• Email: info@coligne.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640173163664 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051089

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[07640173163664]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-28

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