OneLIF™ 011-713-0004

GUDID G07001171300040

Starter Trial, Large, 13deg, 8mm AH - 4PH

Novapproach Spine LLC

Spinal implant trial

• Primary Device ID: G07001171300040
• NIH Device Record Key: f19d8050-49c4-4840-8c58-0bb543529aa5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneLIF™
• Version Model Number: 011-713-0004
• Catalog Number: 011-713-0004
• Company DUNS: 059260001
• Company Name: Novapproach Spine 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(385)588-3408
• Email: ron.green@novapproachspine.com
• Phone: +1(385)588-3408
• Email: ron.green@novapproachspine.com
• Phone: +1(385)588-3408
• Email: ron.green@novapproachspine.com
• Phone: +1(385)588-3408
• Email: ron.green@novapproachspine.com
• Phone: +1(385)588-3408
• Email: ron.green@novapproachspine.com
• Phone: +1(385)588-3408
• Email: ron.green@novapproachspine.com
• Phone: +1(385)588-3408
• Email: ron.green@novapproachspine.com
• Phone: +1(385)588-3408
• Email: ron.green@novapproachspine.com
• Phone: +1(385)588-3408
• Email: ron.green@novapproachspine.com
• Phone: +1(385)588-3408
• Email: ron.green@novapproachspine.com
• Phone: +1(385)588-3408
• Email: ron.green@novapproachspine.com
• Phone: +1(385)588-3408
• Email: ron.green@novapproachspine.com
• Phone: +1(385)588-3408
• Email: ron.green@novapproachspine.com
• Phone: +1(385)588-3408
• Email: ron.green@novapproachspine.com
• Phone: +1(385)588-3408
• Email: ron.green@novapproachspine.com
• Phone: +1(385)588-3408
• Email: ron.green@novapproachspine.com
• Phone: +1(385)588-3408
• Email: ron.green@novapproachspine.com
• Phone: +1(385)588-3408
• Email: ron.green@novapproachspine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G07001171300040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211769

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-01
• Device Publish Date: 2023-02-21

On-Brand Devices [OneLIF™]

• G07001500100000: Straight Inserter Assembly
• G07001200145280: Bone Screw, Self-Drilling, 4.5 mm, 28 mm
• G07001132522090: Trial-OneLIF Interbody, Large, 25 Degree, 22mm X 9mm
• G07001032522090: OneLIF Interbody, Large, 25 Degree, 22mm X 9mm
• G07001021312060: OneLIF Interbody, Medium, 13 Degree, 12mm X 6mm
• G07001020714110: OneLIF Interbody, Medium, 7 Degree, 14mm X 11mm
• G07001020712090: OneLIF Interbody, Medium, 7 Degree, 12mm X 9mm
• G07001501200010: Tamp Attachment
• G07001501100000: Retention Plate Guide
• G07001501000000: Torque Limit Adapter, AO (female) -1/4" (male) torque 2.25Nm
• G07001500900000: T15 Retention Screwdriver Blade-AO Drive
• G07001500700000: Bone Screw Srewdriver Blade-Str Tip, 1/4" Drive, T15 (retaining)
• G07001500600000: Modular Screwdriver handle-Fixed, 1/4" Drive, color RAL5015 color blue
• G07001400000000: Retention Plate Screw
• G07001330012220: Retention Plate, Large, 12 mm - 22 mm
• G07001330011220: Retention Plate, Large, 11 mm - 22 mm
• G07001330010000: Retention Plate, Large, 10 mm
• G07001320012200: Retention Plate, Medium, 12 mm - 20 mm
• G07001320011190: Retention Plate, Medium, 11 mm - 19 mm
• G07001320010000: Retention Plate, Medium, 10 mm
• G07001310012180: Retention Plate, Small, 12 mm - 18 mm
• G07001310011180: Retention Plate, Small, 11 mm - 18 mm
• G07001310010000: Retention Plate, Small, 10 mm
• G07001200345280: Bone Screw, Cancellous, Self-Drilling, 4.5 mm, 28 mm
• G07001200345240: Bone Screw, Cancellous, Self-Drilling, 4.5 mm, 24 mm
• G07001200345200: Bone Screw, Cancellous, Self-Drilling, 4.5 mm, 20 mm
• G07001200345160: Bone Screw, Cancellous, Self-Drilling, 4.5 mm, 16 mm
• G07001200340280: Bone Screw, Cancellous, Self-Drilling, 4.0 mm, 28 mm
• G07001200340240: Bone Screw, Cancellous, Self-Drilling, 4.0 mm, 24 mm
• G07001200340200: Bone Screw, Cancellous, Self-Drilling, 4.0 mm, 20 mm
• G07001200340160: Bone Screw, Cancellous, Self-Drilling, 4.0 mm, 16 mm
• G07001200145240: Bone Screw, Self-Drilling, 4.5 mm, 24 mm
• G07001200145200: Bone Screw, Self-Drilling, 4.5 mm, 20 mm
• G07001200145160: Bone Screw, Self-Drilling, 4.5 mm, 16 mm
• G07001200140280: Bone Screw, Self-Drilling, 4.0 mm, 28 mm
• G07001200140240: Bone Screw, Self-Drilling, 4.0 mm, 24 mm
• G07001200140200: Bone Screw, Self-Drilling, 4.0 mm, 20 mm
• G07001200140160: Bone Screw, Self-Drilling, 4.0 mm, 16 mm
• G07001132520070: Trial-OneLIF Interbody, Large, 25 Degree, 20mm X 7mm
• G07001131920100: Trial-OneLIF Interbody, Large, 19 Degree, 20mm X 10mm
• G07001131918080: Trial-OneLIF Interbody, Large, 19 Degree, 18mm X 8mm
• G07001131916060: Trial-OneLIF Interbody, Large, 19 Degree, 16mm X 6mm
• G07001131320130: Trial-OneLIF Interbody, Large, 13 Degree, 20mm X 13mm
• G07001131318110: Trial-OneLIF Interbody, Large, 13 Degree, 18mm X 11mm
• G07001131316090: Trial-OneLIF Interbody, Large, 13 Degree, 16mm X 9mm
• G07001131314070: Trial-OneLIF Interbody, Large, 13 Degree, 14mm X 7mm
• G07001131312050: Trial-OneLIF Interbody, Large, 13 Degree, 12mm X 5mm
• G07001130716120: Trial-OneLIF Interbody, Large, 7 Degree, 16mm X 12mm
• G07001130714100: Trial-OneLIF Interbody, Large, 7 Degree, 14mm X 10mm
• G07001130712080: Trial-OneLIF Interbody, Large, 7 Degree, 12mm X 8mm