CoLink™ Screw

GUDID 00817906021394

Ø3.0 x 38mm,Transverse

IN2BONES USA, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00817906021394
• NIH Device Record Key: 66a17322-8ec6-4429-8ea2-f615abb01ab3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoLink™ Screw
• Version Model Number: V30 ST438
• Company DUNS: 079700711
• Company Name: IN2BONES USA, LLC
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817906021394 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163293

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-07-28

On-Brand Devices [CoLink™ Screw]

• 00817906021400: Ø3.0 x 40mm,Transverse
• 00817906021394: Ø3.0 x 38mm,Transverse
• 00817906021387: Ø3.0 x 36mm,Transverse
• 00817906021370: Ø3.0 x 34mm,Transverse
• 00817906021363: Ø3.0 x 32mm,Transverse
• 00817906021356: Ø3.0 x 30mm,Transverse
• 00817906021349: Ø3.0 x 28mm,Transverse
• 00817906021332: Ø3.0 x 26mm,Transverse
• 00817906021325: Ø3.0 x 24mm,Transverse
• 00817906021318: Ø3.0 x 22mm,Transverse
• 00817906021301: Ø3.0 x 20mm,Transverse
• 00817906021295: Ø3.0 x 18mm,Transverse