Spatz FGIA, Inc. services our international customer base via direct sales and through a global network of independent distributors in Canada, Latin America, Europe, Asia and the Middle East.
This device is not approved by the FDA for use in the United States
The Spatz™ Adjustable Balloon System is now available in the following countries:
- Czech Republic
- Middle East
- South Africa
- South Korea
- United Kingdom
Spatz Worldwide Partners:
Authorized SPATZ Clinics in Mexico (close to the US border):
Spatz FGIA, Inc. maintains a formal quality system meeting the requirements of ISO 13485 and Medical Device Directive 93/42/EEC and other international regulatory requirements. Our products are authorized to bear the CE mark.
This device is not approved by the FDA for use in the United States.