CONDUIT ATP 4mm Spreader 24° 287363244

GUDID 09421028118446

Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.

ENZTEC LIMITED

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 09421028118446
• NIH Device Record Key: 1fcfb020-cbbe-47d9-8e56-f69299a2e6de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONDUIT ATP 4mm Spreader 24°
• Version Model Number: 287363244
• Catalog Number: 287363244
• Company DUNS: 592616445
• Company Name: ENZTEC LIMITED
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09421028118446 [Primary]

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[09421028118446]

Moist Heat or Steam Sterilization

[09421028118446]

Moist Heat or Steam Sterilization

[09421028118446]

Moist Heat or Steam Sterilization

[09421028118446]

Moist Heat or Steam Sterilization

[09421028118446]

Moist Heat or Steam Sterilization

[09421028118446]

Moist Heat or Steam Sterilization

[09421028118446]

Moist Heat or Steam Sterilization

[09421028118446]

Moist Heat or Steam Sterilization

[09421028118446]

Moist Heat or Steam Sterilization

[09421028118446]

Moist Heat or Steam Sterilization

[09421028118446]

Moist Heat or Steam Sterilization

[09421028118446]

Moist Heat or Steam Sterilization

[09421028118446]

Moist Heat or Steam Sterilization

[09421028118446]

Moist Heat or Steam Sterilization

[09421028118446]

Moist Heat or Steam Sterilization

[09421028118446]

Moist Heat or Steam Sterilization

[09421028118446]

Moist Heat or Steam Sterilization

[09421028118446]

Moist Heat or Steam Sterilization

[09421028118446]

Moist Heat or Steam Sterilization

[09421028118446]

Moist Heat or Steam Sterilization

[09421028118446]

Moist Heat or Steam Sterilization

[09421028118446]

Moist Heat or Steam Sterilization

[09421028118446]

Moist Heat or Steam Sterilization

[09421028118446]

Moist Heat or Steam Sterilization

[09421028118446]

Moist Heat or Steam Sterilization

[09421028118446]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-12
• Device Publish Date: 2023-12-04

Devices Manufactured by ENZTEC LIMITED

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• 09421028118651 - Adjustable Cutting Block – 1.35mm: 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028118668 - 3.5mm Ball Hex Driver – 340mm: 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028118705 - MODULAR BROACH HANDLE, DUAL OFFSET, RIGHT: 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028118712 - MODULAR BROACH HANDLE, DUAL OFFSET, LEFT: 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119030 - Adjustable Cutting Block – 1.27mm: 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119085 - MODULAR BROACH HANDLE, GRIP: 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119092 - MODULAR BROACH HANDLE, STRIKE PLATE: 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure