ExactechGPS Ankle Application 541-00-01

GUDID 10885862634979

GPS Ankle Implant Kit

Exactech, Inc.

Orthopaedic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 10885862634979
• NIH Device Record Key: 44d9b910-cc0c-412f-bdef-d8a32d8c66f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ExactechGPS Ankle Application
• Version Model Number: 541-00-01
• Catalog Number: 541-00-01
• Company DUNS: 157565946
• Company Name: Exactech, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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	10885862634979 [Primary]

FDA Product Code

• KDD: Kit, surgical instrument, disposable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-08
• Device Publish Date: 2025-07-31

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
• 10885862634979: GPS Ankle Implant Kit