FDA Registration
Active
🇺🇸 United States
Lapidus Cut Guide Disposable Set
Reg #: 3009540749
·
FEI: 3009540749
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
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
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 |
|---|---|---|---|---|---|
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2022-10-10 |
Proprietary Names
Lapidus Cut Guide Disposable Set
Lapiprep Lapidus Preparation System
StealthFix Intraosseous Fixation System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility