FDA Registration
Active
🇨🇭 Switzerland
APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System
Reg #: 3003236702
·
FEI: 3003236702
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- MEDARTIS AG
- Registration Number
- 3003236702
- FEI Number
- 3003236702
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- HOCHBERGERSTRASSE 60E
- City
- BASEL Basel-Stadt
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K202589
Owner / Operator
- Firm Name
- MEDARTIS AG
- Operator Number
- 9033581
- Address
- HOCHBERGERSTRASSE 60E, --
- City
- BASEL
- State
- Basel-Stadt
- Postal Code
- CH-4057
- Country
- CH
US Agent
- Business Name
- Medartis Inc.
- Contact Name
- Elise Fox
- Address
- 1195 Polk Drive
- City
- Warsaw
- State
- IN
- ZIP
- 46582
- Country
- US
- [email protected]
- Phone
- 574 3762062
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2020-11-11 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2020-11-11 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2020-11-11 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-11-11 |
Proprietary Names
APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System
Establishment Types
Manufacture Medical Device