2100-0005

GUDID 00817577022751

THREADED BENDING RODS

Exactech, Inc.

Orthopaedic fixation implant alignment tool

• Primary Device ID: 00817577022751
• NIH Device Record Key: 3b47742b-0cfa-42a3-9ea3-7456cbb7d181
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2100-0005
• Catalog Number: 2100-0005
• 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	00817577022751 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153340

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00817577022751]

Moist Heat or Steam Sterilization

[00817577022751]

Moist Heat or Steam Sterilization

[00817577022751]

Moist Heat or Steam Sterilization

[00817577022751]

Moist Heat or Steam Sterilization

[00817577022751]

Moist Heat or Steam Sterilization

[00817577022751]

Moist Heat or Steam Sterilization

[00817577022751]

Moist Heat or Steam Sterilization

[00817577022751]

Moist Heat or Steam Sterilization

[00817577022751]

Moist Heat or Steam Sterilization

[00817577022751]

Moist Heat or Steam Sterilization

[00817577022751]

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

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• 10885862636430 - Truliant: 2025-02-07 Special Extended Femoral IM Rod Slap Hammer Adapter
• 10885862653260 - Truliant: 2025-01-16 Special Universal Baseplate Tibial Trial, Size 1
• 10885862653277 - Truliant: 2025-01-16 Special Universal Baseplate Tibial Trial, Size 2
• 10885862653284 - Truliant: 2025-01-16 Special Universal Baseplate Tibial Trial, Size 3