CoLink™ View

GUDID 00817906020380

Lapidus Plate,+2 mm with PEEK Insert, Left

IN2BONES USA, LLC

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

• Primary Device ID: 00817906020380
• NIH Device Record Key: 127a1e91-dee7-493d-bdca-2c3a236f05a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoLink™ View
• Version Model Number: P40 ST261
• 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

Customer Support Contacts

• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817906020380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172300

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: 2018-09-10
• Device Publish Date: 2018-08-10

On-Brand Devices [CoLink™ View ]

• 00817906024197: Lapidus Transverse Insert, L, PEEK
• 00817906024180: Lapidus Transverse Insert, R, PEEK
• 00817906024173: Y-Plate Transverse Insert, PEEK
• 00817906024166: MTP Transverse Insert, PEEK
• 00817906021462: Y-Plate Compression Insert, Ti
• 00817906021455: Lapidus/MTP Compression Insert , Ti
• 00817906021448: Y-Plate Transverse Insert, Ti
• 00817906021431: Lapidus Transverse Insert, L, Ti
• 00817906021424: Lapidus Transverse Insert, R, Ti
• 00817906021417: MTP Transverse Insert, Ti
• 00817906020397: Y-Plate, 5-Hole with Peek Insert
• 00817906020380: Lapidus Plate,+2 mm with PEEK Insert, Left
• 00817906020373: Lapidus Plate,+2 mm with PEEK Insert, Right
• 00817906020366: Lapidus Plate,+1 mm with PEEK Insert, Left
• 00817906020359: Lapidus Plate,+1 mm with PEEK Insert, Right
• 00817906020342: Lapidus Plate, Std. with PEEK Insert, Left
• 00817906020335: Lapidus Plate, Std. with PEEK Insert, Right
• 00817906020304: MTP Plate, 6-Hole with PEEK Insert, Left
• 00817906020298: MTP Plate, 6-Hole with PEEK Insert, Right
• 00817906020281: MTP Plate, 5-Hole with PEEK Insert, Left
• 00817906020274: MTP Plate, 5-Hole with PEEK Insert, Right