Fracture and Correction CoLag™ 2

GUDID 00817906025002

SCREW, Ø2.0X8.0 mm

IN2BONES USA, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00817906025002
• NIH Device Record Key: 7833e4ef-c2b8-49ba-adc9-24502f7c63a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fracture and Correction CoLag™ 2
• Version Model Number: P67 ST108
• 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	00817906025002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180377

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

On-Brand Devices [Fracture and Correction CoLag™ 2]

• 00817906025699: SCREW, Ø4.0X32.0 mm
• 00817906025682: SCREW, Ø4.0X30.0 mm
• 00817906025675: SCREW, Ø4.0X28.0 mm
• 00817906025668: SCREW, Ø4.0X26.0 mm
• 00817906025651: SCREW, Ø4.0X24.0 mm
• 00817906025644: SCREW, Ø4.0X22.0 mm
• 00817906025637: SCREW, Ø4.0X20.0 mm
• 00817906025620: SCREW, Ø3.0X40.0 mm
• 00817906025613: SCREW, Ø3.0X38.0 mm
• 00817906025606: SCREW, Ø3.0X36.0 mm
• 00817906025590: SCREW, Ø3.0X34.0 mm
• 00817906025583: SCREW, Ø3.0X32.0 mm
• 00817906025576: SCREW, Ø3.0X30.0 mm
• 00817906025569: SCREW, Ø3.0X28.0 mm
• 00817906025552: SCREW, Ø3.0X26.0 mm
• 00817906025545: SCREW, Ø3.0X24.0 mm
• 00817906025538: SCREW, Ø3.0X22.0 mm
• 00817906025521: SCREW, Ø3.0X20.0 mm
• 00817906025514: SCREW, Ø3.0X18.0 mm
• 00817906025507: SCREW, Ø3.0X16.0 mm
• 00817906025491: SCREW, Ø3.0X14.0 mm
• 00817906025484: SCREW, Ø3.0X12.0 mm
• 00817906025477: SCREW, Ø2.5X55.0 mm
• 00817906025460: SCREW, Ø2.5X52.5 mm
• 00817906025453: SCREW, Ø2.5X50.0 mm
• 00817906025446: SCREW, Ø2.5X47.5 mm
• 00817906025439: SCREW, Ø2.5X45.0 mm
• 00817906025422: SCREW, Ø2.5X42.5 mm
• 00817906025415: SCREW, Ø2.5X40.0 mm
• 00817906025408: SCREW, Ø2.5X37.5 mm
• 00817906025392: SCREW, Ø2.5X35.0 mm
• 00817906025385: SCREW, Ø2.5X32.5 mm
• 00817906025378: SCREW, Ø2.5X30.0 mm
• 00817906025361: SCREW, Ø2.5X28.0 mm
• 00817906025354: SCREW, Ø2.5X26.0 mm
• 00817906025347: SCREW, Ø2.5X24.0 mm
• 00817906025330: SCREW, Ø2.5X22.0 mm
• 00817906025323: SCREW, Ø2.5X20.0 mm
• 00817906025316: SCREW, Ø2.5X18.0 mm
• 00817906025309: SCREW, Ø2.5X16.0 mm
• 00817906025293: SCREW, Ø2.5X14.0 mm
• 00817906025286: SCREW, Ø2.5X12.0 mm
• 00817906025279: SCREW, Ø2.5X10.0 mm
• 00817906025262: SCREW, Ø2.5X8.0 mm
• 00817906025255: SCREW, Ø2.0X55.0 mm
• 00817906025248: SCREW, Ø2.0X52.5 mm
• 00817906025231: SCREW, Ø2.0X50.0 mm
• 00817906025224: SCREW, Ø2.0X47.5 mm
• 00817906025217: SCREW, Ø2.0X45.0 mm
• 00817906025200: SCREW, Ø2.0X42.5 mm