CoLink® NeoFuse

GUDID 00810021865065

TARGETING GUIDE, ANTERO-LATERAL, LEFT

IN2BONES USA, LLC

Surgical drill guide, reusable

• Primary Device ID: 00810021865065
• NIH Device Record Key: 5072830c-51b3-46cf-93fc-d1066562a8cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoLink® NeoFuse
• Version Model Number: P02 N0091
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00810021865065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213069

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00810021865065]

Moist Heat or Steam Sterilization

[00810021865065]

Moist Heat or Steam Sterilization

[00810021865065]

Moist Heat or Steam Sterilization

[00810021865065]

Moist Heat or Steam Sterilization

[00810021865065]

Moist Heat or Steam Sterilization

[00810021865065]

Moist Heat or Steam Sterilization

[00810021865065]

Moist Heat or Steam Sterilization

[00810021865065]

Moist Heat or Steam Sterilization

[00810021865065]

Moist Heat or Steam Sterilization

[00810021865065]

Moist Heat or Steam Sterilization

[00810021865065]

Moist Heat or Steam Sterilization

[00810021865065]

Moist Heat or Steam Sterilization

[00810021865065]

Moist Heat or Steam Sterilization

[00810021865065]

Moist Heat or Steam Sterilization

[00810021865065]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-31
• Device Publish Date: 2022-01-21

On-Brand Devices [CoLink® NeoFuse]

• 00810021865850: CoLink®, Ø4.5 mm VA Locking Screws, 65 mm
• 00810021865843: CoLink®, Ø4.5 mm VA Locking Screws, 60 mm
• 00810021865836: CoLink®, Ø4.5 mm VA Locking Screws, 55 mm
• 00810021865829: CoLink®, Ø4.5 mm VA Locking Screws, 50 mm
• 00810021865812: CoLink®, Ø4.5 mm VA Locking Screws, 45 mm
• 00810021865805: CoLink®, Ø4.5 mm VA Locking Screws, 40 mm
• 00810021865799: CoLink®, Ø4.5 mm VA Locking Screws, 38 mm
• 00810021865782: CoLink®, Ø4.5 mm VA Locking Screws, 36 mm
• 00810021865775: CoLink®, Ø4.5 mm VA Locking Screws, 34 mm
• 00810021865768: CoLink®, Ø4.5 mm VA Locking Screws, 32 mm
• 00810021865751: CoLink®, Ø4.5 mm VA Locking Screws, 30 mm
• 00810021865744: CoLink®, Ø4.5 mm VA Locking Screws, 28 mm
• 00810021865737: CoLink®, Ø4.5 mm VA Locking Screws, 26 mm
• 00810021865720: CoLink®, Ø4.5 mm VA Locking Screws, 24 mm
• 00810021865713: CoLink®, Ø4.5 mm VA Locking Screws, 22 mm
• 00810021865706: CoLink®, Ø4.5 mm VA Locking Screws, 20 mm
• 00810021865690: CoLink®, Ø4.5 mm VA Locking Screws, 18 mm
• 00810021865683: CoLink®, Ø4.5 mm VA Locking Screws, 16 mm
• 00810021865676: CoLink®, Ø4.5 mm Locking Screws, 65 mm
• 00810021865669: CoLink®, Ø4.5 mm Locking Screws, 60 mm
• 00810021865652: CoLink®, Ø4.5 mm Locking Screws, 55 mm
• 00810021865645: CoLink®, Ø4.5 mm Locking Screws, 50 mm
• 00810021865638: CoLink®, Ø4.5 mm Locking Screws, 45 mm
• 00810021865621: CoLink®, Ø4.5 mm Locking Screws, 40 mm
• 00810021865614: CoLink®, Ø4.5 mm Locking Screws, 38 mm
• 00810021865607: CoLink®, Ø4.5 mm Locking Screws, 36 mm
• 00810021865591: CoLink®, Ø4.5 mm Locking Screws, 34 mm
• 00810021865584: CoLink®, Ø4.5 mm Locking Screws, 32 mm
• 00810021865577: CoLink®, Ø4.5 mm Locking Screws, 30 mm
• 00810021865560: CoLink®, Ø4.5 mm Locking Screws, 28 mm
• 00810021865553: CoLink®, Ø4.5 mm Locking Screws, 26 mm
• 00810021865546: CoLink®, Ø4.5 mm Locking Screws, 24 mm
• 00810021865539: CoLink®, Ø4.5 mm Locking Screws, 22 mm
• 00810021865522: CoLink®, Ø4.5 mm Locking Screws, 20 mm
• 00810021865515: CoLink®, Ø4.5 mm Locking Screws, 18 mm
• 00810021865508: CoLink®, Ø4.5 mm Locking Screws, 16 mm
• 00810021865492: CoLink®, Ø4.5 mm Non-Locking Screws, 100 mm
• 00810021865485: CoLink®, Ø4.5 mm Non-Locking Screws, 95 mm
• 00810021865478: CoLink®, Ø4.5 mm Non-Locking Screws, 90 mm
• 00810021865461: CoLink®, Ø4.5 mm Non-Locking Screws, 85 mm
• 00810021865454: CoLink®, Ø4.5 mm Non-Locking Screws, 80 mm
• 00810021865447: CoLink®, Ø4.5 mm Non-Locking Screws, 75 mm
• 00810021865430: CoLink®, Ø4.5 mm Non-Locking Screws, 70 mm
• 00810021865423: CoLink®, Ø4.5 mm Non-Locking Screws, 65 mm
• 00810021865416: CoLink®, Ø4.5 mm Non-Locking Screws, 60 mm
• 00810021865409: CoLink®, Ø4.5 mm Non-Locking Screws, 55 mm
• 00810021865393: CoLink®, Ø4.5 mm Non-Locking Screws, 50 mm
• 00810021865386: CoLink®, Ø4.5 mm Non-Locking Screws, 45 mm
• 00810021865379: CoLink®, Ø4.5 mm Non-Locking Screws, 40 mm
• 00810021865362: CoLink®, Ø4.5 mm Non-Locking Screws, 38 mm