FDA Registration
Active
🇨🇭 Switzerland
SF Push-in Anchor 2.3
Reg #: 3022518322
·
FEI: 3022518322
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- SURGICAL FUSION TECHNOLOGIES GmbH
- Registration Number
- 3022518322
- FEI Number
- 3022518322
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Wagistrasse 6
- City
- Schlieren Zurich
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K171228
Owner / Operator
- Firm Name
- Surgical Fusion Technologies
- Operator Number
- 10084998
- Address
- Wagistrasse 6
- City
- Schlieren
- State
- Zurich
- Postal Code
- 8952
- Country
- CH
- Correspondent
- Felix A Kraeft
US Agent
- Business Name
- GLW, Inc.
- Contact Name
- Arundhati Radhakrishnan
- Address
- 930 Sylvan Ave Ste 125
- City
- Englewood Cliffs
- State
- NJ
- ZIP
- 07632
- Country
- US
- [email protected]
- Phone
- 917 4562939
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2022-04-25 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2022-04-25 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2022-04-25 |
Proprietary Names
SF Push-in Anchor 2.3
SupraFuser B Ultrasonic Generator
SupraFuser B Ultrasonic Handpiece
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility