02-019-30-0301

GUDID 10885862291219

STEM EXTENSION TRIAL RECOVERY TOOL

Exactech, Inc.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 10885862291219
• NIH Device Record Key: d7c61e19-ad89-43ea-87a1-5c2508c0cfad
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 02-019-30-0301
• Catalog Number: 02-019-30-0301
• 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	10885862291219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150890

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

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

[10885862291219]

Moist Heat or Steam Sterilization

[10885862291219]

Moist Heat or Steam Sterilization

[10885862291219]

Moist Heat or Steam Sterilization

[10885862291219]

Moist Heat or Steam Sterilization

[10885862291219]

Moist Heat or Steam Sterilization

[10885862291219]

Moist Heat or Steam Sterilization

[10885862291219]

Moist Heat or Steam Sterilization

[10885862291219]

Moist Heat or Steam Sterilization

[10885862291219]

Moist Heat or Steam Sterilization

[10885862291219]

Moist Heat or Steam Sterilization

[10885862291219]

Moist Heat or Steam Sterilization

[10885862291219]

Moist Heat or Steam Sterilization

[10885862291219]

Moist Heat or Steam Sterilization

[10885862291219]

Moist Heat or Steam Sterilization

[10885862291219]

Moist Heat or Steam Sterilization

[10885862291219]

Moist Heat or Steam Sterilization

[10885862291219]

Moist Heat or Steam Sterilization

[10885862291219]

Moist Heat or Steam Sterilization

[10885862291219]

Moist Heat or Steam Sterilization

[10885862291219]

Moist Heat or Steam Sterilization

[10885862291219]

Moist Heat or Steam Sterilization

[10885862291219]

Moist Heat or Steam Sterilization

[10885862291219]

Moist Heat or Steam Sterilization

[10885862291219]

Moist Heat or Steam Sterilization

[10885862291219]

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.

• 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