113-10-00

GUDID 10885862017239

OSTEOTOMY GUIDE

Exactech, Inc.

Osteotomy guide, reusable

• Primary Device ID: 10885862017239
• NIH Device Record Key: 43980230-8b0e-4693-9b31-5b4cf97bc003
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 113-10-00
• Catalog Number: 113-10-00
• 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	10885862017239 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041906

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

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

[10885862017239]

Moist Heat or Steam Sterilization

[10885862017239]

Moist Heat or Steam Sterilization

[10885862017239]

Moist Heat or Steam Sterilization

[10885862017239]

Moist Heat or Steam Sterilization

[10885862017239]

Moist Heat or Steam Sterilization

[10885862017239]

Moist Heat or Steam Sterilization

[10885862017239]

Moist Heat or Steam Sterilization

[10885862017239]

Moist Heat or Steam Sterilization

[10885862017239]

Moist Heat or Steam Sterilization

[10885862017239]

Moist Heat or Steam Sterilization

[10885862017239]

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.

• 10885862591357 - Equinoxe: 2025-04-15 KS K-Wire Block, Left
• 10885862591364 - Equinoxe: 2025-04-15 KS K-Wire Block, Right
• 10885862655639 - Vantage: 2025-04-15 Special Vantage Sharp Reamer, Straight Blade, Flat Tip - 15mm Tall x 12mm Diameter
• 10885862655646 - Vantage: 2025-04-15 Special Vantage Sharp Reamer, Straight Blade, Cone Tip - 15mm Tall x 12mm Diameter
• 10885862655653 - Vantage: 2025-04-15 Special Vantage Sharp Reamer, Helix Blade, Flat Tip - 15mm Tall x 12mm Diameter
• 10885862655660 - Vantage: 2025-04-15 Special Vantage Sharp Reamer, Helix Blade, Cone Tip - 15mm Tall x 12mm Diameter
• 10885862604699 - Equinoxe: 2025-03-28 Humeral Reconstruction Prothesis MIDDLE SEGMENT TRIAL, 25mm
• 10885862604705 - Equinoxe: 2025-03-28 Humeral Reconstruction Prothesis MIDDLE SEGMENT TRIAL, 50mm