CoLink Mini

GUDID 00817906029420

Straight Plate, 4H

IN2BONES USA, LLC

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

• Primary Device ID: 00817906029420
• NIH Device Record Key: 55cfe8c7-60fc-4e56-8581-af433a066bf8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoLink Mini
• Version Model Number: P90 ST014
• 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	00817906029420 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191535

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-07
• Device Publish Date: 2019-09-27

On-Brand Devices [CoLink Mini]

• 00817906029574: T-Plate, 7H, Trial
• 00817906029567: T-Plate, 5H, Trial
• 00817906029550: Straight Plate, 8H, Trial
• 00817906029543: Straight Plate, 6H, Trial
• 00817906029536: Straight Plate, 4H, Trial
• 00817906029529: Straight Plate, 3H, Trial
• 00817906029512: Straight Plate, 2H, Trial
• 00817906029505: Oblique L Plate, 7H, Left, Trial
• 00817906029499: Oblique L Plate, 7H, Right, Trial
• 00817906029482: Oblique L Plate, 5H, Left, Trial
• 00817906029475: Oblique L Plate, 5H, Right, Trial
• 00817906029468: T-Plate, 7H
• 00817906029451: T-Plate, 5H
• 00817906029444: Straight Plate, 8H
• 00817906029437: Straight Plate, 6H
• 00817906029420: Straight Plate, 4H
• 00817906029413: Straight Plate, 3H
• 00817906029406: Straight Plate, 2H
• 00817906029390: Oblique L Plate, 7H, Left
• 00817906029383: Oblique L Plate, 7H, Right
• 00817906029376: Oblique L Plate, 5H, Left
• 00817906029369: Oblique L Plate, 5H, Right
• 00810021860329: Locking Drill Guide, Ø1.9
• 00810021860312: Locking Drill Guide, Ø1.6