ExactechGPS Ankle Application 03-GNB-CB-0002

GUDID 10885862631312

3D/3D+ Tibial Cut Tracker

Exactech, Inc.

Orthopaedic stereotactic surgery system

• Primary Device ID: 10885862631312
• NIH Device Record Key: eb8a70d9-e121-4a02-bd8f-bfe6d7b4ea33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ExactechGPS Ankle Application
• Version Model Number: 03-GNB-CB-0002
• Catalog Number: 03-GNB-CB-0002
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	10885862631312 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232521

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[10885862631312]

Moist Heat or Steam Sterilization

[10885862631312]

Moist Heat or Steam Sterilization

[10885862631312]

Moist Heat or Steam Sterilization

[10885862631312]

Moist Heat or Steam Sterilization

[10885862631312]

Moist Heat or Steam Sterilization

[10885862631312]

Moist Heat or Steam Sterilization

[10885862631312]

Moist Heat or Steam Sterilization

[10885862631312]

Moist Heat or Steam Sterilization

[10885862631312]

Moist Heat or Steam Sterilization

[10885862631312]

Moist Heat or Steam Sterilization

[10885862631312]

Moist Heat or Steam Sterilization

[10885862631312]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-28
• Device Publish Date: 2024-10-18

On-Brand Devices [ExactechGPS Ankle Application]

• 10885862632777: Bone Fixator
• 10885862631374: Pin Guide
• 10885862631343: 3D/3D+ Cut Checker
• 10885862631336: Cut Checker
• 10885862631329: Talar Cut Tracker
• 10885862631312: 3D/3D+ Tibial Cut Tracker
• 10885862631305: Tibial Cut Tracker