01-001-01-0001

GUDID 10885862256577

MODULAR STEM INSERTER, STRAIGHT

Exactech, Inc.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 10885862256577
• NIH Device Record Key: b523126a-56b8-4e3d-82ee-be1f3bf53f0c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 01-001-01-0001
• Catalog Number: 01-001-01-0001
• 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	10885862256577 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140674

FDA Product Code

• MEH: Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

Sterilization

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

[10885862256577]

Moist Heat or Steam Sterilization

[10885862256577]

Moist Heat or Steam Sterilization

[10885862256577]

Moist Heat or Steam Sterilization

[10885862256577]

Moist Heat or Steam Sterilization

[10885862256577]

Moist Heat or Steam Sterilization

[10885862256577]

Moist Heat or Steam Sterilization

[10885862256577]

Moist Heat or Steam Sterilization

[10885862256577]

Moist Heat or Steam Sterilization

[10885862256577]

Moist Heat or Steam Sterilization

[10885862256577]

Moist Heat or Steam Sterilization

[10885862256577]

Moist Heat or Steam Sterilization

[10885862256577]

Moist Heat or Steam Sterilization

[10885862256577]

Moist Heat or Steam Sterilization

[10885862256577]

Moist Heat or Steam Sterilization

[10885862256577]

Moist Heat or Steam Sterilization

[10885862256577]

Moist Heat or Steam Sterilization

[10885862256577]

Moist Heat or Steam Sterilization

[10885862256577]

Moist Heat or Steam Sterilization

[10885862256577]

Moist Heat or Steam Sterilization

[10885862256577]

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.

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• 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