FDA Registration
Active
🇩🇪 Germany
OsteoBridge IKA Knee Arthrodesis Nail without Collar
Reg #: 3014314623
·
FEI: 3014314623
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Aristotech Industries GmbH
- Registration Number
- 3014314623
- FEI Number
- 3014314623
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Alt-Lankwitz 102
- City
- Berlin
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K101939
Owner / Operator
- Firm Name
- Aristotech Industries GmbH
- Operator Number
- 10053573
- Address
- Im Biotechnologiepark
- City
- Luckenwalde
- State
- Brandenburg
- Postal Code
- 14943
- Country
- DE
- Correspondent
- Jens-Erik Wegner
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2018-01-23 |
Proprietary Names
OsteoBridge IKA Knee Arthrodesis Nail without Collar
OsteoBridge Interlocking Screw
OsteoBridge IKA Knee Arthrodesis Nail with Collar
OsteoBridge IKA Knee Arthrodesis 10 Spacer
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)