521-40-15

GUDID 10885862546357

LPI TKA PLUS FEMORAL RES GUIDE

Exactech, Inc.

Orthopaedic stereotactic surgery system

• Primary Device ID: 10885862546357
• NIH Device Record Key: 1e553c13-7742-4454-9834-60551558ccdb
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 521-40-15
• Catalog Number: 521-40-15
• 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	10885862546357 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100742

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[10885862546357]

Moist Heat or Steam Sterilization

[10885862546357]

Moist Heat or Steam Sterilization

[10885862546357]

Moist Heat or Steam Sterilization

[10885862546357]

Moist Heat or Steam Sterilization

[10885862546357]

Moist Heat or Steam Sterilization

[10885862546357]

Moist Heat or Steam Sterilization

[10885862546357]

Moist Heat or Steam Sterilization

[10885862546357]

Moist Heat or Steam Sterilization

[10885862546357]

Moist Heat or Steam Sterilization

[10885862546357]

Moist Heat or Steam Sterilization

[10885862546357]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-05
• Device Publish Date: 2022-07-28

Devices Manufactured by Exactech, Inc.

• 10885862636201 - Truliant: 2024-10-16 Special Tibial Cut Block MIS, 0 Degree, Left
• 10885862636218 - Truliant: 2024-10-16 Special Tibial Cut Block MIS, 0 Degree, Right
• 10885862291042 - Vantage: 2024-10-08 Talar Mill Block – Size 1
• 10885862636331 - Equinoxe: 2024-10-03 HUMERAL TRAY TRIAL +0
• 10885862636348 - Equinoxe: 2024-10-03 HUMERAL TRAY TRIAL +5MM
• 10885862636355 - Equinoxe: 2024-10-03 HUMERAL TRAY TRIAL +10MM
• 10885862632685 - Vantage: 2024-09-23 Special Corner Chisel
• 10885862566522 - Vantage: 2024-09-05 Posterior Capsule Removal Tool