FDA device listing
10 GEL BAG ONLY,AFO PEDIATRICO, EXTRA-LARGE LEFT,AFO PEDIATRICO, EXTRA-LARGE RIGHT,AFO Pediatrico, Extra Small Left,AFO…
FDA device listing 1577428295 · TIBURON MEDICAL ENTERPRISES
Key facts
| Proprietary names | 10 GEL BAG ONLY,AFO PEDIATRICO, EXTRA-LARGE LEFT,AFO PEDIATRICO, EXTRA-LARGE RIGHT,AFO Pediatrico, Extra Small Left,AFO Pediatrico, Extra Small Right,AFO PEDIATRICO, LARGE LEFT,AFO PEDIATRICO, LARGE RIGHT,AFO PEDIATRICO, MEDIUM LEFT,AFO PEDIATRICO, MEDIUM RIGHT,AFO PEDIATRICO, SMALL LEFT,AFO PEDIATRICO, SMALL RIGHT,Ambulatory Podus Boot, Extra Large,Ambulatory Podus Boot, Standard,AnklBlckTC1501… |
|---|---|
| Owner/operator | TIBURON MEDICAL ENTERPRISES |
| Owner/operator number | 9040187 |
| Product codes | ITW |
| Device names | ITW - Joint, Ankle, External Brace |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | TIBURON MEDICAL ENTERPRISES, Zeffer Research & Assoc. S. A. de C. V. |
| Establishment registrations | 2031918, 3007392395 |
| FEI numbers | 3002935344, 3007392395 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database