01-001-01-0003

GUDID 10885862256591

MODULAR STEM INSERTER, THREADED

Exactech, Inc.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 10885862256591
• NIH Device Record Key: 7e415232-f060-46ad-814e-718d908d717e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 01-001-01-0003
• Catalog Number: 01-001-01-0003
• 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	10885862256591 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140674

FDA Product Code

• KWY: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Sterilization

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

[10885862256591]

Moist Heat or Steam Sterilization

[10885862256591]

Moist Heat or Steam Sterilization

[10885862256591]

Moist Heat or Steam Sterilization

[10885862256591]

Moist Heat or Steam Sterilization

[10885862256591]

Moist Heat or Steam Sterilization

[10885862256591]

Moist Heat or Steam Sterilization

[10885862256591]

Moist Heat or Steam Sterilization

[10885862256591]

Moist Heat or Steam Sterilization

[10885862256591]

Moist Heat or Steam Sterilization

[10885862256591]

Moist Heat or Steam Sterilization

[10885862256591]

Moist Heat or Steam Sterilization

[10885862256591]

Moist Heat or Steam Sterilization

[10885862256591]

Moist Heat or Steam Sterilization

[10885862256591]

Moist Heat or Steam Sterilization

[10885862256591]

Moist Heat or Steam Sterilization

[10885862256591]

Moist Heat or Steam Sterilization

[10885862256591]

Moist Heat or Steam Sterilization

[10885862256591]

Moist Heat or Steam Sterilization

[10885862256591]

Moist Heat or Steam Sterilization

[10885862256591]

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.

• 10885862033017 - Novation: 2025-05-09
• 10885862250865 - Alteon: 2025-05-09
• 10885862250902 - Alteon: 2025-05-09
• 10885862594891 - Alteon: 2025-05-08 Alteon Short Tapered Wedge Broach, Chip Breaker Tooth, Size 1
• 10885862594907 - Alteon: 2025-05-08 Alteon Short Tapered Wedge Broach, Chip Breaker Tooth, Size 2
• 10885862594914 - Alteon: 2025-05-08 Alteon Short Tapered Wedge Broach, Chip Breaker Tooth, Size 3
• 10885862594921 - Alteon: 2025-05-08 Alteon Short Tapered Wedge Broach, Chip Breaker Tooth, Size 4
• 10885862594938 - Alteon: 2025-05-08 Alteon Short Tapered Wedge Broach, Chip Breaker Tooth, Size 5