LapiLock

GUDID 00840124511361

LapiLock Instrumentation Kit (No Implants Included)

FUSION ORTHOPEDICS, LLC

Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00840124511361
• NIH Device Record Key: 91426a88-eccb-4031-b9be-fecb7d08d620
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LapiLock
• Version Model Number: CD-LL-1000-S
• 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: true
• 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	00840124511361 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211843

FDA Product Code

• KDD: Kit, Surgical Instrument, Disposable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-09
• Device Publish Date: 2024-04-01

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)