FDA Registration
Active
🇩🇪 Germany
Ankle Joint Bar
Reg #: 9616494
·
FEI: 3003117657
·
Expires 2025
Products
1
Proprietary Names
31
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH
- Registration Number
- 9616494
- FEI Number
- 3003117657
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Max-Naeder-Strasse 15
- City
- DUDERSTADT Lower Saxony
- Country
- DE
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
US Agent
- Business Name
- Otto Bock HealthCare LP
- Contact Name
- Caleb Beck
- Address
- 3820 West Great Lakes Drive
- City
- Salt Lake City
- State
- UT
- ZIP
- 84120
- Country
- US
- [email protected]
- Phone
- 801 9746647
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stirrup, External Brace Component | ITC | Class 1 | Physical Medicine | No | 1996-03-29 |
Proprietary Names
Ankle Joint Bar
Pelvic Band
System-Split Stirrup
System-Side Bar Set-Alum.
System-Caliper Plate
System-Side Bar Set-S.S.
System Lamination Joint Bar
Unilateral ankle joint C-Brace
Unilateral Knee Joint
Syst. Ring Lock Joint Head
Split Stirrup
Nexgear Posterior Knee
System Stirrup, forked
Framework for DTO
System Side Bar Set
System-Full-Stirrup
Nexgear Free Knee
C-Brace medial follower
CarbonIQ System Knee Joint , Aqualine orthotic knee joint
Medial Follower
System-Verlangerungsteile-Satz
Lamination lancet UL Joint
Nexgear Lock Knee
Aqualine Ankle Joint
Foot Stirrup, stainless steel
Power unit for correction joints
System-Full Stirrup
System Lamin. Joint Bar w.Contoured Calf
System Shoe Stirrup, Double Sided
Extension wedge set for 17KF210
Extension wedge set for 17KF210=*-10-*-*
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device