FDA Registration
Active
🇨🇭 Switzerland
MUTARS® rasp for femoral stem 16mm
Reg #: 3010314800
·
FEI: 3010314800
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INNOTOOL&GREMINGER AG
- Registration Number
- 3010314800
- FEI Number
- 3010314800
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Fabrikstrasse 1E
- City
- Erlen Thurgau
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K181778
Owner / Operator
- Firm Name
- innotool & greminger ag
- Operator Number
- 10043239
- Address
- Fabrikstrasse 1E
- City
- Erlen
- State
- Thurgau
- Postal Code
- 8586
- Country
- CH
- Correspondent
- Enver Memeti
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2024-12-19 |
Proprietary Names
MUTARS® rasp for femoral stem 16mm
MUTARS® rasp for femoral stem 20mm
MUTARS® rasp for femoral stem 17mm
MUTARS® rasp for femoral stem 19mm
MUTARS® rasp for femoral stem 12mm
MUTARS® rasp for femoral stem 13mm
MUTARS® rasp for femoral stem 15mm
MUTARS® rasp for femoral stem 14mm
MUTARS® rasp for femoral stem 18mm
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)