Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012638928

FEI Number

3015409025

Entity Name

SPATZ FGIA INC.

City/State/Country

Ra'anana Central, IL

Establishment Address

Ha-Tidhar 2, Ra'anana Central 4366504, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Spatz FGIA Inc. (Owner Number: 10083108)

Owner / Operator Contact Address

1801 S Perimeter Road STE 130, Fort Lauderdale, FL 33309, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P190012

All Registered Proprietary Names

Spatz3 Adjustable Balloon System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LTI	Implant, Intragastric For Morbid Obesity	Unknown	Class 3	N/A	2021-10-26

Official Correspondent

Pnina Polishuk

US Agent Details

David Harris Business: Spatz FGIA Inc. Email: dharris@spatzmedical.com Phone: (703) 7395695

Related Public Records

Same Entity

Spatz FGIA Inc.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012638928. Last updated year: 2026. Please use registration number 3012638928 when referencing this establishment in official correspondence.