FDA Registration
Active
🇩🇪 Germany
OsteoBridge" IKA Knee Arthrodesis curved Nail without Collar
Reg #: 3014314623
·
FEI: 3014314623
·
Expires 2025
Products
1
Proprietary Names
3
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
- K120978
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 | 2018-01-24 |
Proprietary Names
OsteoBridge" IKA Knee Arthrodesis curved Nail without Collar
OsteoBridge" IKA Knee Arthrodesis Nail without Collar dia extension
OsteoBridge" IKA Knee Arthrodesis Nail with Collar dia and length extension
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)