Data / Medical devices / Israel / Spatz Fgia Inc.
Spatz Fgia Inc.: FDA-registered device maker in Ra'anana Central, Israel, 1 PMA approval
Spatz Fgia Inc. is registered with the FDA (registration 3012638928) in Ra'anana Central, Israel. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated October 15, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012638928
- FEI number
- 3015409025
- Address
- Ha-Tidhar 2, Ra'anana Central, Israel, 4366504
- Owner or operator
- Spatz FGIA Inc. (10083108)
- Roles
- Manufacturer
- First device listed
- October 26, 2021
- Registered through
- 2026
- Brand names listed
- Spatz3 Adjustable Balloon System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Implant, Intragastric For Morbid Obesity | LTI | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| October 15, 2021 | P190012 | Spatz3 Adjustable Balloon System | LTI | 3 | February 29, 2024 | accessdata.fda.gov |
Compare with other makers
Updated February 29, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.