FDA Registration
Active
🇫🇷 France
arcad® 2 Duo & Quadro Osteosynthesis Compressive Staple
Reg #: 3010673777
·
FEI: 3010673777
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- NOVASTEP
- Registration Number
- 3010673777
- FEI Number
- 3010673777
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2 allee Jacques Frimot
- City
- RENNES Bretagne
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K230724
Owner / Operator
- Firm Name
- Trilliant Surgical
- Operator Number
- 10027494
- Address
- 727 N. Shepherd Dr., STE 100
- City
- Houston
- State
- TX
- Postal Code
- 77007
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2023-12-11 |
Proprietary Names
arcad® 2 Duo & Quadro Osteosynthesis Compressive Staple
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device