CoLink

GUDID 00810021860374

LOW-PRO CORTICAL SCREW, Ø2.4X12MM

IN2BONES USA, LLC

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

• Primary Device ID: 00810021860374
• NIH Device Record Key: 8a01d8b3-53af-433a-899e-31b68e970d11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoLink
• Version Model Number: P92 ST012
• 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	00810021860374 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191535

FDA Product Code

• HWC: Screw, 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]

• 00817906028720: MTP Plate Trial-5Hole-Left
• 00817906028713: MTP Plate Trial-5Hole- Right
• 00817906028140: MTP Plate Trial-NX-Left
• 00817906028133: MTP Plate Trial-NX-Right
• 00817906028126: MTP Plate Trial-Revision-Left
• 00817906028119: MTP Plate Trial-Revision-Right
• 00817906028102: MTP Plate Trial-6 Hole-Left
• 00817906028096: MTP Plate Trial-6 Hole-Right
• 00817906028089: H-Plate Plate Trial, LG
• 00817906028072: H-Plate Plate Trial, MD
• 00817906028065: H-Plate Plate Trial, SM
• 00817906028058: Y-Plate, 5-Hole Plate Trial
• 00817906028041: Lapidus, +2mm, Plate Trial, Left
• 00817906028034: Lapidus, +2mm, Plate Trial, Right
• 00817906028027: Lapidus, +1 mm, Plate Trial, Left
• 00817906028010: Lapidus, +1 mm, Plate Trial, Right
• 00817906028003: Lapidus, Standard, Plate Trial, Left
• 00817906027990: Lapidus, Standard, Plate Trial, Right
• 00817906027983: Universal Plate Trial- 6 Hole
• 00817906027976: Universal Plate Trial- 5 Hole
• 00817906027969: Universal Plate Trial- 4 Hole
• 00817906027952: Universal Plate Trial- 3 Hole
• 00817906027945: Universal Plate Trial- 2-Hole
• 00817906027938: Tranverse Drill Guide Assembly, 3.0 Screw
• 00817906027921: Locking drill guide-for 2.5 drill
• 00817906027914: Locking drill guide-for 2.0 drill
• 00810021861043: VAL SCREW, Ø2.4X50MM
• 00810021861036: VAL SCREW, Ø2.4X47.5MM
• 00810021861029: VAL SCREW, Ø2.4X45MM
• 00810021861012: VAL SCREW, Ø2.4X42.5MM
• 00810021861005: VAL SCREW, Ø2.4X40MM
• 00810021860992: VAL SCREW, Ø2.4X37.5MM
• 00810021860985: VAL SCREW, Ø2.4X35MM
• 00810021860978: VAL SCREW, Ø2.4X32.5MM
• 00810021860961: VAL SCREW, Ø2.4X30MM
• 00810021860954: VAL SCREW, Ø2.4X28MM
• 00810021860947: VAL SCREW, Ø2.4X26MM
• 00810021860930: VAL SCREW, Ø2.4X24MM
• 00810021860923: VAL SCREW, Ø2.4X22MM
• 00810021860916: VAL SCREW, Ø2.4X20MM
• 00810021860909: VAL SCREW, Ø2.4X18MM
• 00810021860893: VAL SCREW, Ø2.4X16MM
• 00810021860886: VAL SCREW, Ø2.4X15MM
• 00810021860879: VAL SCREW, Ø2.4X14MM
• 00810021860862: VAL SCREW, Ø2.4X13MM
• 00810021860855: VAL SCREW, Ø2.4X12MM
• 00810021860848: VAL SCREW, Ø2.4X11MM
• 00810021860831: VAL SCREW, Ø2.4X10MM
• 00810021860824: VAL SCREW, Ø2.4X9MM
• 00810021860817: VAL SCREW, Ø2.4X8MM