Nextremity General Instrument

GUDID 00817701028482

Lapidus Cut Guide Disposable Set

NEXTREMITY SOLUTIONS, INC.

Orthopaedic prosthesis implantation instrument, single-use

• Primary Device ID: 00817701028482
• NIH Device Record Key: f1412c31-d948-4ac0-b032-61272aa1c36e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nextremity General Instrument
• Version Model Number: LCGKIT
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817701028482 [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: 2022-05-12
• Device Publish Date: 2022-05-04

Devices Manufactured by NEXTREMITY SOLUTIONS, INC.

• 00810082893885 - Stealthfix Intraosseous Fixation System: 2022-08-12 StealthFix Ti Implant 3.5mm Post x 15mm Span x 14mm Long
• 00810082893892 - Stealthfix Intraosseous Fixation System: 2022-08-12 StealthFix Ti Implant 3.5mm Post x 15mm Span x 16mm Long
• 00810082893908 - Stealthfix Intraosseous Fixation System: 2022-08-12 StealthFix Ti Implant 3.5mm Post x 15mm Span x 18mm Long
• 00810082893915 - Stealthfix Intraosseous Fixation System: 2022-08-12 StealthFix Ti Implant 3.5mm Post x 15mm Span x 20mm Long
• 00810082893922 - Stealthfix Intraosseous Fixation System: 2022-08-12 StealthFix Ti Implant 4.5mm Post x 15mm Span x 14mm Long
• 00810082893939 - Stealthfix Intraosseous Fixation System: 2022-08-12 StealthFix Ti Implant 4.5mm Post x 15mm Span x 16mm Long
• 00810082893946 - Stealthfix Intraosseous Fixation System: 2022-08-12 StealthFix Ti Implant 4.5mm Post x 15mm Span x 18mm Long
• 00810082893953 - Stealthfix Intraosseous Fixation System: 2022-08-12 StealthFix Ti Implant 4.5mm Post x 15mm Span x 20mm Long