OneLIF™ 015-022-0000

GUDID G07001502200000

Retention Plate Inserter Sheath

Novapproach Spine LLC

Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable

Primary Device ID	G07001502200000
NIH Device Record Key	4eb81e4d-73c1-4ca4-866e-f1caafef281f
Commercial Distribution Status	In Commercial Distribution
Brand Name	OneLIF™
Version Model Number	015-022-0000
Catalog Number	015-022-0000
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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G07001502200000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K211769

FDA Product Code

MAX	Intervertebral fusion device with bone graft, 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	2022-11-30
Device Publish Date	2022-11-22

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

Trademark Results [OneLIF]

Mark Image Registration \| Serial	Company Trademark Application Date
ONELIF 90678064 not registered Live/Pending	NovApproach Spine, LLC 2021-04-28