FDA Registration
Active
🇺🇸 United States
Acu-Sinch Knotless - Mini
Reg #: 3008396464
·
FEI: 3008396464
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Acumed LLC -Brookwood Facility
- Registration Number
- 3008396464
- FEI Number
- 3008396464
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4860 NE Brookwood Parkway
- City
- Hillsboro
- State
- OR
- ZIP
- 97124
- Country
- US
Regulatory Submissions
- 510(k) Number
- K243624
Owner / Operator
- Firm Name
- ACUMED LLC
- Operator Number
- 9001805
- Address
- 5885 NE CORNELIUS PASS RD., --
- City
- Hillsboro
- State
- OR
- Postal Code
- 97124
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2025-05-05 |
Proprietary Names
Acu-Sinch Knotless - Mini
Establishment Types
Manufacture Medical Device