OPTIX OX2-0011

GUDID 00841731147431

OPTIX H2 PSI Guide Bundle Flat Cut & Chamfer Cut Combo

VILEX LLC

Custom-made orthopaedic/craniofacial surgical guide

• Primary Device ID: 00841731147431
• NIH Device Record Key: 511c7926-4cba-4bb7-af27-d7f963c63ca2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTIX
• Version Model Number: OX2-0011
• Catalog Number: OX2-0011
• Company DUNS: 117502293
• Company Name: VILEX 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: true
• 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	00841731147431 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230462

FDA Product Code

• OYK: Ankle Arthroplasty Implantation System

Sterilization

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

[00841731147431]

Moist Heat or Steam Sterilization

[00841731147431]

Moist Heat or Steam Sterilization

[00841731147431]

Moist Heat or Steam Sterilization

[00841731147431]

Moist Heat or Steam Sterilization

[00841731147431]

Moist Heat or Steam Sterilization

[00841731147431]

Moist Heat or Steam Sterilization

[00841731147431]

Moist Heat or Steam Sterilization

[00841731147431]

Moist Heat or Steam Sterilization

[00841731147431]

Moist Heat or Steam Sterilization

[00841731147431]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-11
• Device Publish Date: 2026-03-03

Devices Manufactured by VILEX LLC

• 00841731135490 - TITANEX: 2026-03-11 ARTEMIS Zadex Beam dia 6.5x40.0mm
• 00841731147431 - OPTIX: 2026-03-11OPTIX H2 PSI Guide Bundle Flat Cut & Chamfer Cut Combo
• 00841731147431 - OPTIX: 2026-03-11 OPTIX H2 PSI Guide Bundle Flat Cut & Chamfer Cut Combo
• 00841731149077 - DYNEX MICRO: 2026-03-11 DYNEX Mini Rail Pin Extender
• 00841731137548 - TITANEX: 2026-02-17 TITANEX MICROBEAM 2.0 X 16MM
• 00841731137555 - TITANEX: 2026-02-17 TITANEX MICROBEAM 2.0 X 18MM
• 00841731137562 - TITANEX: 2026-02-17 TITANEX MICROBEAM 2.0 X 20MM
• 00841731137579 - TITANEX: 2026-02-17 TITANEX MICROBEAM 2.0 X 22MM
• 00841731137586 - TITANEX: 2026-02-17 TITANEX MICROBEAM 2.0 X 24MM