FDA Registration
Active
🇺🇸 United States
APTUS K-Wire System
Reg #: 3009540749
·
FEI: 3009540749
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Medartis Inc.
- Registration Number
- 3009540749
- FEI Number
- 3009540749
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1195 Polk Drive
- City
- Warsaw
- State
- IN
- ZIP
- 46582
- Country
- US
Regulatory Submissions
- 510(k) Number
- K092038
Owner / Operator
- Firm Name
- MEDARTIS AG
- Operator Number
- 9033581
- Address
- HOCHBERGERSTRASSE 60E, --
- City
- BASEL
- State
- Basel-Stadt
- Postal Code
- CH-4057
- Country
- CH
- Correspondent
- Claudia De Santis
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2010-12-10 |
Proprietary Names
APTUS K-Wire System
Establishment Types
Repack or Relabel Medical Device