Lapiprep Lapidus Preparation System

GUDID 00810082897852

LapiPrep 4in K-Wire Sterile Packed Set

NEXTREMITY SOLUTIONS, INC.

Orthopaedic prosthesis implantation instrument, single-use

• Primary Device ID: 00810082897852
• NIH Device Record Key: 0c73297b-86ed-4967-808f-432cb35b6ae5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lapiprep Lapidus Preparation System
• Version Model Number: LPKWIRES
• Company DUNS: 060783407
• Company Name: NEXTREMITY SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810082897852 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

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: 2022-08-11
• Device Publish Date: 2022-08-03

On-Brand Devices [Lapiprep Lapidus Preparation System]

• 00810082897852: LapiPrep 4in K-Wire Sterile Packed Set
• 00810082897845: Saw Blade Sterile
• 00810082897838: Saw Blade
• 00810082897821: LapiPrep Instrument Case - Lid
• 00810082897814: LapiPrep Instrument Case - Tray
• 00810082897807: LapiPrep Ratcheting AO Handle
• 00810082897739: LapiPrep Compression Screw
• 00810082897722: LapiPrep 4in K-Wire
• 00810082897715: LapiPrep Screwdriver
• 00810082897708: LapiPrep ML positioning Pin
• 00810082897692: LapiPrep Metatarsal Offset Paddle
• 00810082897685: LapiPrep Tissue Retractor
• 00810082897678: LapiPrep Sagittal Plane Adjustment Screw
• 00810082897661: LapiPrep Pronation Trolley
• 00810082897654: LapiPrep Pronation Rail
• 00810082897647: LapiPrep IM Closer Trolley - Right
• 00810082897630: LapiPrep IM Closer Trolley - Left
• 00810082897623: LapiPrep Cut Guide Attachment - Right
• 00810082897616: LapiPrep Cut Guide Attachment - Left
• 00810082897609: LapiPrep Positioning Paddle Attachment -Right
• 00810082897593: LapiPrep Positioning Paddle Attachment -Left
• 00810082897586: LapiPrep Compression Frame Assembly - Right
• 00810082897579: LapiPrep Compression Frame Assembly - Left