PolyLock Small Bone TN-SB-7104

GUDID 00840124507487

MiniLock K-Wire Lag Guide

FUSION ORTHOPEDICS, LLC

Surgical drill guide, single-use

• Primary Device ID: 00840124507487
• NIH Device Record Key: 2e72ccdb-0df5-4f87-a67f-ccac585ae178
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PolyLock Small Bone
• Version Model Number: TN-SB-7104
• Catalog Number: TN-SB-7104
• Company DUNS: 080307067
• Company Name: FUSION ORTHOPEDICS, LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• 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	00840124507487 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211843

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00840124507487]

Moist Heat or Steam Sterilization

[00840124507487]

Moist Heat or Steam Sterilization

[00840124507487]

Moist Heat or Steam Sterilization

[00840124507487]

Moist Heat or Steam Sterilization

[00840124507487]

Moist Heat or Steam Sterilization

[00840124507487]

Moist Heat or Steam Sterilization

[00840124507487]

Moist Heat or Steam Sterilization

[00840124507487]

Moist Heat or Steam Sterilization

[00840124507487]

Moist Heat or Steam Sterilization

[00840124507487]

Moist Heat or Steam Sterilization

[00840124507487]

Moist Heat or Steam Sterilization

[00840124507487]

Moist Heat or Steam Sterilization

[00840124507487]

Moist Heat or Steam Sterilization

[00840124507487]

Moist Heat or Steam Sterilization

[00840124507487]

Moist Heat or Steam Sterilization

[00840124507487]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-09
• Device Publish Date: 2024-08-01

On-Brand Devices [PolyLock Small Bone]

• 00840124506329: Lapidus U Plate Right
• 00840124506312: Lapidus U Plate Left
• 00840124506718: Non-Locking Screw SB 2.7mm x 32mm
• 00840124507159: Olive Wire 2.0mm Threaded
• 00840124513730: TailorsLock Plate (New)
• 00840124513723: TailorsLock Tray
• 00840124507487: MiniLock K-Wire Lag Guide