FDA device listing
Cybercross TLSO,Cyberspine TLSOx4,Dosi EQ,Extension Orthosis,Ottobock TLSO,Postural Extension,Smartspine Extension…
FDA device listing 1342657848 · Ottobock SE & Co. KGaA
Key facts
| Proprietary names | Cybercross TLSO,Cyberspine TLSOx4,Dosi EQ,Extension Orthosis,Ottobock TLSO,Postural Extension,Smartspine Extension Brace,Smartspine SI Support |
|---|---|
| Owner/operator | Ottobock SE & Co. KGaA |
| Owner/operator number | 8010097 |
| Product codes | IPT |
| Device names | IPT - Orthosis, Thoracic |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3490 |
| Review panels | Physical Medicine |
| Registered establishments | OTTO BOCK HEALTHCARE CANADA, OTTO BOCK HEALTHCARE LP, OTTO BOCK ITALIA SRL, Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH |
| Establishment registrations | 1721652, 9616494, 1000228440, 3001917653 |
| FEI numbers | 1721652, 1000228440, 3001917653, 3003117657 |
| Establishment operations | Foreign Exporter, Manufacturer, Specification Developer |
| 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