Facility

NOVAPPROACH SPINE, LLC

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3020307303
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	13900 Tech City Circle Alachua, FL, US 32615
Registration status	Active · expires 2026
Parent company	NovApproach Spine, LLC (owner-operator 10082697)
Brand names	OneLIF Interbody Fusion System

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (2)

Intervertebral Fusion Device With Bone Graft, Lumbar
Product code MAX (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3080
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Product code OVD (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3080

Recalls & enforcement

Class IIOngoing2026-04-23
Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and/or the need to select an alternative implant.
Class IITerminated2022-10-12
The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.

FDA inspections (1)

NAI2025-09-17
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by NovApproach Spine, LLC

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “NOVAPPROACH SPINE, LLC (FEI 3020307303) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3020307303-novapproach-spine-llc/

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