CoLink® 2

GUDID 00810021862781

CoLink® 2 Lapidus Plate XP,+1 mm, Left

IN2BONES USA, LLC

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

• Primary Device ID: 00810021862781
• NIH Device Record Key: 1d04f6d1-8084-4d46-9bac-0da1f0d60ce8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoLink® 2
• Version Model Number: P42 ST255
• Company DUNS: 079700711
• Company Name: IN2BONES USA, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	00810021862781 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201149

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: 2020-09-14
• Device Publish Date: 2020-09-04

On-Brand Devices [CoLink® 2]

• 00810021863696: CoLink® VAL Screw, Ø3.0 X 60mm
• 00810021863689: CoLink® VAL Screw, Ø3.0 X 57.5mm
• 00810021863672: CoLink® VAL Screw, Ø3.0 X 55mm
• 00810021863665: CoLink® VAL Screw, Ø3.0 X 52.5mm
• 00810021863658: CoLink® VAL Screw, Ø3.0 X 50mm
• 00810021863641: CoLink® VAL Screw, Ø3.0 X 47.5mm
• 00810021863634: CoLink® VAL Screw, Ø3.0 X 45mm
• 00810021863627: CoLink® VAL Screw, Ø3.0 X 42.5mm
• 00810021863610: CoLink® VAL Screw, Ø3.0 X 40mm
• 00810021863603: CoLink® VAL Screw, Ø3.0 X 38mm
• 00810021863597: CoLink® VAL Screw, Ø3.0 X 36mm
• 00810021863580: CoLink® VAL Screw, Ø3.0 X 34mm
• 00810021863573: CoLink® VAL Screw, Ø3.0 X 32mm
• 00810021863566: CoLink® VAL Screw, Ø3.0 X 30mm
• 00810021863559: CoLink® VAL Screw, Ø3.0 X 28mm
• 00810021863542: CoLink® VAL Screw, Ø3.0 X 26mm
• 00810021863535: CoLink® VAL Screw, Ø3.0 X 24mm
• 00810021863528: CoLink® VAL Screw, Ø3.0 X 22mm
• 00810021863511: CoLink® VAL Screw, Ø3.0 X 20mm
• 00810021863504: CoLink® VAL Screw, Ø3.0 X 18mm
• 00810021863498: CoLink® VAL Screw, Ø3.0 X 16mm
• 00810021863481: CoLink® VAL Screw, Ø3.0 X 14mm
• 00810021863474: CoLink® VAL Screw, Ø3.0 X 12mm
• 00810021863467: CoLink® VAL Screw, Ø3.0 X 10mm
• 00810021863450: CoLink® VAL Screw, Ø3.0 X 8mm
• 00810021863443: CoLink® Locking Screw, Ø3.0 X 60mm
• 00810021863436: CoLink® Locking Screw, Ø3.0 X 57.5mm
• 00810021863429: CoLink® Locking Screw, Ø3.0 X 55mm
• 00810021863412: CoLink® Locking Screw, Ø3.0 X 52.5mm
• 00810021863405: CoLink® Locking Screw, Ø3.0 X 50mm
• 00810021863399: CoLink® Locking Screw, Ø3.0 X 47.5mm
• 00810021863382: CoLink® Locking Screw, Ø3.0 X 45mm
• 00810021863375: CoLink® Locking Screw, Ø3.0 X 42.5mm
• 00810021863368: CoLink® Locking Screw, Ø3.0 X 40mm
• 00810021863351: CoLink® Locking Screw, Ø3.0 X 38mm
• 00810021863344: CoLink® Locking Screw, Ø3.0 X 36mm
• 00810021863337: CoLink® Locking Screw, Ø3.0 X 34mm
• 00810021863320: CoLink® Locking Screw, Ø3.0 X 32mm
• 00810021863313: CoLink® Locking Screw, Ø3.0 X 30mm
• 00810021863306: CoLink® Locking Screw, Ø3.0 X 28mm
• 00810021863290: CoLink® Locking Screw, Ø3.0 X 26mm
• 00810021863283: CoLink® Locking Screw, Ø3.0 X 24mm
• 00810021863276: CoLink® Locking Screw, Ø3.0 X 22mm
• 00810021863269: CoLink® Locking Screw, Ø3.0 X 20mm
• 00810021863252: CoLink® Locking Screw, Ø3.0 X 18mm
• 00810021863245: CoLink® Locking Screw, Ø3.0 X 16mm
• 00810021863238: CoLink® Locking Screw, Ø3.0 X 14mm
• 00810021863221: CoLink® Locking Screw, Ø3.0 X 12mm
• 00810021863214: CoLink® Locking Screw, Ø3.0 X 10mm
• 00810021863207: CoLink® Locking Screw, Ø3.0 X 8mm