Lumbar Interbody Fusion System (OLLIF) Inserter- Outer 01-00-1

GUDID 00850014575014

OLLIF Inserter-Outer

ADVANCED RESEARCH MEDICAL LLC

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00850014575014
• NIH Device Record Key: c5880971-aa85-4e9c-99b2-fd3baad15f88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumbar Interbody Fusion System (OLLIF) Inserter- Outer
• Version Model Number: 01-00-1
• Catalog Number: 01-00-1
• Company DUNS: 117201206
• Company Name: ADVANCED RESEARCH MEDICAL LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com
• Phone: (612) 440-1865
• Email: info@advresmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850014575014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173947

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument
• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

[00850014575014]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-31
• Device Publish Date: 2019-12-23

On-Brand Devices [Lumbar Interbody Fusion System (OLLIF) Inserter- Outer]

• 00850014575045: OLLIF Inserter-Inner
• 00850014575014: OLLIF Inserter-Outer