FDA Registration
Active
🇺🇸 United States
Smartspine Extension Brace
Reg #: 1721652
·
FEI: 1721652
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OTTO BOCK HEALTHCARE LP
- Registration Number
- 1721652
- FEI Number
- 1721652
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3820 West Great Lakes Drive
- City
- Salt Lake City
- State
- UT
- ZIP
- 84120
- Country
- US
Owner / Operator
- Firm Name
- Ottobock SE & Co. KGaA
- Operator Number
- 8010097
- Address
- Max-Naeder-Strasse 15
- City
- Duderstadt
- State
- Lower Saxony
- Postal Code
- 37115
- Country
- DE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2005-07-28 |
Proprietary Names
Smartspine Extension Brace
Postural Extension
Dosi EQ
Ottobock TLSO
Cybercross TLSO
Extension Orthosis
Smartspine SI Support
Cyberspine TLSOx4
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility