Facility

ATLAS SPINE INC.

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

Key facts

2recalls · worst Class II

3inspections · worst VAI

—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)	3003855635
Establishment type	Manufacture Medical Device
Location	1555 Jupiter Park Dr Ste 1 JUPITER, FL, US 33458
Registration status	Active · expires 2026
Parent company	ATLAS SPINE INC. (owner-operator 9053705)
Brand names	Apelo Pedicle Screw System

Activity by year

Recalls (2)
Inspections (3)

Devices registered here (3)

Orthosis, Spondylolisthesis Spinal Fixation
Product code MNH (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3070
Orthosis, Spinal Pedicle Fixation
Product code MNI (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3070
Thoracolumbosacral Pedicle Screw System
Product code NKB (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3070

Recalls & enforcement

Class IITerminated2013-07-26
The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.
Class IITerminated2009-06-04
Atlas Spine, Inc. recalled their Apelo Modular Screwdriver, a component of the Apelo Pedicle Screw System Instrumentation, because of complaints received about the tip breaking. If the tip is fractured inside of the modular screw, the tip could become implanted in the body or if …

FDA inspections (3)

VAI2025-05-27
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2022-12-06
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2019-07-19
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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 ATLAS SPINE INC.

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. “ATLAS SPINE INC. (FEI 3003855635) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003855635-atlas-spine-inc/

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