Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020307303

FEI Number

3020307303

Entity Name

NOVAPPROACH SPINE, LLC

City/State/Country

Alachua, FL, US

Establishment Address

13900 Tech City Circle, Suite 300, Alachua, FL 32615, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

NovApproach Spine, LLC (Owner Number: 10082697)

Owner / Operator Contact Address

13900 Tech City Circle, Suite 300, Alachua, FL 32615, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211769

PMA Number

N/A

All Registered Proprietary Names

OneLIF Interbody Fusion System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-09-12
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2021-09-12

Official Correspondent

Ronald Green

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NovApproach Spine, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30
K080401	Advanced Medical Technologies AG	SHELL CAGE, WAVE CAGE, LOOP CAGE	2008-05-09
K200084	Zavation Medical Products, LLC	Zavation IBF System	2020-10-19

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020307303. Last updated year: 2026. Please use registration number 3020307303 when referencing this establishment in official correspondence.