Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010676138

FEI Number

3010676138

Entity Name

CURONIX LLC

City/State/Country

Pompano Beach, FL, US

Establishment Address

1310 Park Central Boulevard S, Pompano Beach, FL 33064, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Curonix LLC (Owner Number: 10087444)

Owner / Operator Contact Address

1310 Park Central Blvd S, Pompano Beach, FL 33064, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K172644

PMA Number

N/A

All Registered Proprietary Names

Freedom Spinal Cord Stimulator (SCS) System Freedom Peripheral Nerve Stimulator (PNS) System Spinal Cord Stimulator (SCS) SandShark Injectable Anchor (SIA) Accessory Freedom Spinal Cord Stimulator (SCS) System Freedom Spinal Cord Stimulator (SCS) System Full-Body Freedom PNS System: External Transmitter & Two-Component Neurostimulator with Electrode Array and Receiver Freedom SCS System: External Transmitter and Two Component Implanted Neurostimulator with Electrode Array and Receiver Freedom Spinal Cord Stimulator (SCS) System Freedom Spinal Cord Stimulator (SCS) System Freedom Spinal Cord Stimulator (SCS) System Spinal Cord Stimulator (SCS) SandShark Injectable Anchor (SIA) Accessory

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2023-02-28
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)	Neurology	Class 2	882.5870	2023-02-28
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2023-03-13
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2023-02-28
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2023-02-28
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)	Neurology	Class 2	882.5870	2024-06-26
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2023-02-28
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2023-02-28
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2023-02-28
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2023-02-28
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2023-02-28

Official Correspondent

Jessica Coelho

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Curonix 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
K190960	Boston Scientific Neuromodulation	Nalu Lead Blank (50cm)	2019-07-11
K150517	Stimwave Technologies Incorporated	Freedom Spinal Cord Stimulator System	2015-06-05
K945103	Medtronic Vascular	TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS)	1995-01-11

Similar Registrations

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2024311	PARTER MEDICAL PRODUCTS, INC.	CARSON, CA, US
1035166	OSCOR INC.	PALM HARBOR, FL, US
1928237	MIDWEST STERILIZATION CORP.	JACKSON, MO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010676138. Last updated year: 2026. Please use registration number 3010676138 when referencing this establishment in official correspondence.