LapiLock

GUDID 00840124511156

LapiLock Bone Cut Guide Single Slot

FUSION ORTHOPEDICS, LLC

Custom-made orthopaedic/craniofacial surgical guide

• Primary Device ID: 00840124511156
• NIH Device Record Key: bafbb107-7a6f-4a0f-ac10-82622511100e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LapiLock
• Version Model Number: TN-LL-5102
• 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: false
• 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	00840124511156 [Primary]

FDA Product Code

• HTZ: Instrument, Cutting, Orthopedic

Sterilization

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

[00840124511156]

Moist Heat or Steam Sterilization

[00840124511156]

Moist Heat or Steam Sterilization

[00840124511156]

Moist Heat or Steam Sterilization

[00840124511156]

Moist Heat or Steam Sterilization

[00840124511156]

Moist Heat or Steam Sterilization

[00840124511156]

Moist Heat or Steam Sterilization

[00840124511156]

Moist Heat or Steam Sterilization

[00840124511156]

Moist Heat or Steam Sterilization

[00840124511156]

Moist Heat or Steam Sterilization

[00840124511156]

Moist Heat or Steam Sterilization

[00840124511156]

Moist Heat or Steam Sterilization

[00840124511156]

Moist Heat or Steam Sterilization

[00840124511156]

Moist Heat or Steam Sterilization

[00840124511156]

Moist Heat or Steam Sterilization

[00840124511156]

Moist Heat or Steam Sterilization

[00840124511156]

Moist Heat or Steam Sterilization

[00840124511156]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-22
• Device Publish Date: 2024-01-12

On-Brand Devices [LapiLock]

• 00840124501768: Cutting Block Joint Seeker
• 00840124501751: Cutting Block 5 & 7.5
• 00840124501744: Sagittal Saw 40 mm
• 00840124501720: Fenestration Drill 2.0 mm
• 00840124506039: Olive Wire Threaded
• 00840124506091: Folcrum 4.0 mm
• 00840124506084: Folcrum 3.0mm
• 00840124506077: Folcrum 2.0mm
• 00840124506114: Cutting Block Right
• 00840124506107: Cutting Block Left
• 00840124506381: Short Driver 3.0 mm
• 00840124506374: Olive Wire Short Thread
• 00840124506367: Olive Wire Non-Threaded
• 00840124506350: Fulcrum 5.0 mm
• 00840124506343: Fulcrum Fix
• 00840124506336: Fulcrum Fix Long
• 00840124506411: Cutting Block Parallel
• 00840124506497: Triplanar Correction System Jig Right
• 00840124501713: Triplanar Correction System Jig Left
• 00840124506572: YOCO Blade Double
• 00840124506565: YOCO Single
• 00840124507029: MP Olive Wire Non-Threaded
• 00840124507012: MP Olive Wire Threaded
• 00840124507005: LapiLock Metatarsal Bone Positioner
• 00840124507371: YOCO Single Conmed
• 00840124507364: YOCO Double Conmed
• 00840124507081: YOCO Single Conmed
• 00840124507074: YOCO Double Conmed
• 00840124508972: Sagittal Saw, 40 mm
• 00840124510302: Sagittal Saw Conmed 40mm
• 00840124510319: Sagittal Saw Conmed 40mm Sterile
• 00840124510333: YOCO Lapidus Single
• 00840124510326: YOCO Lapidus Double
• 00840124511156: LapiLock Bone Cut Guide Single Slot
• 00840124506480: Met Cup Subcutaneous
• 00840124511361: LapiLock Instrumentation Kit (No Implants Included)