Fracture and Correction CoLag™2

GUDID 00817906025835

SCREW, Ø5.0X32.0 mm

IN2BONES USA, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00817906025835
• NIH Device Record Key: abf2693e-3f05-4498-bf3d-00685dc3bc9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fracture and Correction CoLag™2
• Version Model Number: P67 ST532
• 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	00817906025835 [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: 2018-09-03
• Device Publish Date: 2018-08-03

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

• 00817906025958: SCREW, Ø5.0X60.0 mm
• 00817906025941: SCREW, Ø5.0X57.5 mm
• 00817906025934: SCREW, Ø5.0X55.0 mm
• 00817906025927: SCREW, Ø5.0X52.5 mm
• 00817906025910: SCREW, Ø5.0X50.0 mm
• 00817906025897: SCREW, Ø5.0X45.0 mm
• 00817906025880: SCREW, Ø5.0X42.5 mm
• 00817906025873: SCREW, Ø5.0X40.0 mm
• 00817906025866: SCREW, Ø5.0X38.0 mm
• 00817906025859: SCREW, Ø5.0X36.0 mm
• 00817906025842: SCREW, Ø5.0X34.0 mm
• 00817906025835: SCREW, Ø5.0X32.0 mm
• 00817906025828: SCREW, Ø5.0X30.0 mm
• 00817906025811: SCREW, Ø4.0X60.0 mm
• 00817906025804: SCREW, Ø4.0X57.5 mm
• 00817906025798: SCREW, Ø4.0X55.0 mm
• 00817906025781: SCREW, Ø4.0X52.5 mm
• 00817906025774: SCREW, Ø4.0X50.0 mm
• 00817906025767: SCREW, Ø4.0X47.5 mm
• 00817906025750: SCREW, Ø4.0X45.0 mm
• 00817906025743: SCREW, Ø4.0X42.5 mm
• 00817906025736: SCREW, Ø4.0X40.0 mm
• 00817906025729: SCREW, Ø4.0X38.0 mm
• 00817906025712: SCREW, Ø4.0X36.0 mm
• 00817906025705: SCREW, Ø4.0X34.0 mm