CoLink® Sfx

GUDID 00810021864181

CoLink® Sfx K-wire 0.045in (1.1mm) x 6.0in with KLIP, Sterile

IN2BONES USA, LLC

Orthopaedic bone wire

• Primary Device ID: 00810021864181
• NIH Device Record Key: 7a82d2e3-857a-4eb0-b32b-f0c59ef26654
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoLink® Sfx
• Version Model Number: K24 SS211
• 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: true
• 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	00810021864181 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203698

FDA Product Code

• HTY: Pin, Fixation, Smooth

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: 2021-08-23
• Device Publish Date: 2021-08-13

On-Brand Devices [CoLink® Sfx]

• 00810021866284: CoLink® Sfx Fixation Implants, 5-Pack, .062x9.0 inches, Single-Use, Sterile
• 00810021866277: CoLink® Sfx Fixation Implants, 5-Pack, .054x9.0 inches, Single-Use, Sterile
• 00810021866260: CoLink® Sfx Fixation Implants, 5-Pack, .054x6.0 inches, Single-Use, Sterile
• 00810021864235: CoLink® Sfx K-wire 0.062in (1.6mm) x 9.0in with KLIP, Sterile
• 00810021864228: CoLink® Sfx K-wire 0.062in (1.6mm) x 6.0in with KLIP, Sterile
• 00810021864211: CoLink® Sfx K-wire 0.054in (1.4mm) x 9.0in with KLIP, Sterile
• 00810021864204: CoLink® Sfx K-wire 0.054in (1.4mm) x 6.0in with KLIP, Sterile
• 00810021864198: CoLink® Sfx K-wire 0.045in (1.1mm) x 9.0in with KLIP, Sterile
• 00810021864181: CoLink® Sfx K-wire 0.045in (1.1mm) x 6.0in with KLIP, Sterile
• 00810021864174: CoLink® Sfx K-wire 0.045in (1.1mm) x 4.0in with KLIP, Sterile
• 00810021864167: CoLink® Sfx K-wire 0.035in (0.9mm) x 4.0in with KLIP, Sterile