CoLink™ Afx

GUDID 00817906026276

MEDIAL TIBIA PLATE, 4-HOLE

IN2BONES USA, LLC

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

• Primary Device ID: 00817906026276
• NIH Device Record Key: 778f9ec0-693a-423f-ac99-4ee7bf179817
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoLink™ Afx
• Version Model Number: P70 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	00817906026276 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181113

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: 2018-09-03
• Device Publish Date: 2018-08-03

On-Brand Devices [CoLink™ Afx ]

• 00817906027884: VAL SCREW, Ø2.7X50MM
• 00817906027877: VAL SCREW, Ø2.7X47.5MM
• 00817906027860: VAL SCREW, Ø2.7X45MM
• 00817906027853: VAL SCREW, Ø2.7X42.5MM
• 00817906027846: VAL SCREW, Ø2.7X40MM
• 00817906027839: VAL SCREW, Ø2.7X37.5MM
• 00817906027822: VAL SCREW, Ø2.7X35MM
• 00817906027815: VAL SCREW, Ø2.7X32.5MM
• 00817906027808: VAL SCREW, Ø2.7X30MM
• 00817906027792: VAL SCREW, Ø2.7X28MM
• 00817906027785: VAL SCREW, Ø2.7X26MM
• 00817906027778: VAL SCREW, Ø2.7X24MM
• 00817906027761: VAL SCREW, Ø2.7X22MM
• 00817906027754: VAL SCREW, Ø2.7X20MM
• 00817906027747: VAL SCREW, Ø2.7X18MM
• 00817906027730: VAL SCREW, Ø2.7X16MM
• 00817906027723: VAL SCREW, Ø2.7X14MM
• 00817906027716: VAL SCREW, Ø2.7X12MM
• 00817906027709: VAL SCREW, Ø2.7X10MM
• 00817906027693: VAL SCREW, Ø2.7X8MM
• 00817906027686: LOCKING SCREW, Ø2.7X50MM
• 00817906027679: LOCKING SCREW, Ø2.7X47.5MM
• 00817906027662: LOCKING SCREW, Ø2.7X45MM
• 00817906027655: LOCKING SCREW, Ø2.7X42.5MM
• 00817906027648: LOCKING SCREW, Ø2.7X40MM
• 00817906027631: LOCKING SCREW, Ø2.7X37.5MM
• 00817906027624: LOCKING SCREW, Ø2.7X35MM
• 00817906027617: LOCKING SCREW, Ø2.7X32.5MM
• 00817906027600: LOCKING SCREW, Ø2.7X30MM
• 00817906027594: LOCKING SCREW, Ø2.7X28MM
• 00817906027587: LOCKING SCREW, Ø2.7X26MM
• 00817906027570: LOCKING SCREW, Ø2.7X24MM
• 00817906027563: LOCKING SCREW, Ø2.7X22MM
• 00817906027556: LOCKING SCREW, Ø2.7X20MM
• 00817906027549: LOCKING SCREW, Ø2.7X18MM
• 00817906027532: LOCKING SCREW, Ø2.7X16MM
• 00817906027525: LOCKING SCREW, Ø2.7X14MM
• 00817906027518: LOCKING SCREW, Ø2.7X12MM
• 00817906027501: LOCKING SCREW, Ø2.7X10MM
• 00817906027495: LOCKING SCREW, Ø2.7X8MM
• 00817906027488: LOW-PRO CORTICAL SCREW, Ø2.7X50MM
• 00817906027471: LOW-PRO CORTICAL SCREW, Ø2.7X47.5MM
• 00817906027464: LOW-PRO CORTICAL SCREW, Ø2.7X45MM
• 00817906027457: LOW-PRO CORTICAL SCREW, Ø2.7X42.5MM
• 00817906027440: LOW-PRO CORTICAL SCREW, Ø2.7X40MM
• 00817906027433: LOW-PRO CORTICAL SCREW, Ø2.7X37.5MM
• 00817906027426: LOW-PRO CORTICAL SCREW, Ø2.7X35MM
• 00817906027419: LOW-PRO CORTICAL SCREW, Ø2.7X32.5MM
• 00817906027402: LOW-PRO CORTICAL SCREW, Ø2.7X30MM
• 00817906027396: LOW-PRO CORTICAL SCREW, Ø2.7X28MM