FDA device listing
Comprehensive LSO,Cyber 8 inch Low-Profile LSO,Cybertech S.P.I.N.E. Brace,Dosi EQ X High,Low Profile LSO,Low Profile LSO…
FDA device listing 1109491126 · Ottobock SE & Co. KGaA
Key facts
| Proprietary names | Comprehensive LSO,Cyber 8 inch Low-Profile LSO,Cybertech S.P.I.N.E. Brace,Dosi EQ X High,Low Profile LSO,Low Profile LSO Lite,MAC Standard,Option 1, Option 2, Option 3,Original 10 inch Standard,Original Cybertech Low Pro 8 inch,Ottobock Fulcrum LSO,Passport LSO,Pathway LS,Premium Plus Low-Profile,SI Belt Low-Profile,Smartspine LSO Low,Smartspine LSO Standard,Smartspine TLSO |
|---|---|
| Owner/operator | Ottobock SE & Co. KGaA |
| Owner/operator number | 8010097 |
| Product codes | IPY |
| Device names | IPY - Orthosis, Lumbo-Sacral |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3490 |
| Review panels | Physical Medicine |
| Registered establishments | OTTO BOCK HEALTHCARE LP, Ottobock Manufacturing Bulgaria EOOD, Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH |
| Establishment registrations | 1721652, 9616494, 3018070833 |
| FEI numbers | 1721652, 3003117657, 3018070833 |
| Establishment operations | Contract Manufacturer, 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