01-019-01-0018

GUDID 10885862284396

18mm TAPERED REAMER REVISION STEM

Exactech, Inc.

Medullary canal orthopaedic reamer, rigid

• Primary Device ID: 10885862284396
• NIH Device Record Key: 9326cbdf-7606-4868-a2e3-c7062573d449
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 01-019-01-0018
• Catalog Number: 01-019-01-0018
• Company DUNS: 157565946
• Company Name: Exactech, Inc.
• 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 Dimensions

• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862284396 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150066

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

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

[10885862284396]

Moist Heat or Steam Sterilization

[10885862284396]

Moist Heat or Steam Sterilization

[10885862284396]

Moist Heat or Steam Sterilization

[10885862284396]

Moist Heat or Steam Sterilization

[10885862284396]

Moist Heat or Steam Sterilization

[10885862284396]

Moist Heat or Steam Sterilization

[10885862284396]

Moist Heat or Steam Sterilization

[10885862284396]

Moist Heat or Steam Sterilization

[10885862284396]

Moist Heat or Steam Sterilization

[10885862284396]

Moist Heat or Steam Sterilization

[10885862284396]

Moist Heat or Steam Sterilization

[10885862284396]

Moist Heat or Steam Sterilization

[10885862284396]

Moist Heat or Steam Sterilization

[10885862284396]

Moist Heat or Steam Sterilization

[10885862284396]

Moist Heat or Steam Sterilization

[10885862284396]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-02
• Device Publish Date: 2022-08-25

Devices Manufactured by Exactech, Inc.

• 10885862657107 - Vantage: 2025-05-20 3D Tibial Cut Block - Size 1
• 10885862657114 - Vantage: 2025-05-20 3D Tibial Cut Block - Size 2
• 10885862657121 - Vantage: 2025-05-20 3D Tibial Cut Block - Size 3
• 10885862657138 - Vantage: 2025-05-20 3D Tibial Cut Block - Size 4
• 10885862657145 - Vantage: 2025-05-20 3D Tibial Cut Block - Size 5
• 10885862657152 - Vantage: 2025-05-20 3D Tibial Cut Block - Size 6
• 10885862657169 - Vantage: 2025-05-20 3D+ Tibial Cut Block - Size 1&2
• 10885862657176 - Vantage: 2025-05-20 3D+ Fork Distractor Tip – Size 3