FDA Registration
Active
🇺🇸 United States
JAWS Nitinol Staple System
Reg #: 3027071765
·
FEI: 3027071765
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SEAWAY PLASTICS ENGINEERING, LLC
- Registration Number
- 3027071765
- FEI Number
- 3027071765
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 16186 Flight Path Drive
- City
- Brooksville
- State
- FL
- ZIP
- 34604
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170923
Owner / Operator
- Firm Name
- Seaway Plastics Engineering, LLC
- Operator Number
- 10087696
- Address
- 16186 Flight Path Drive
- City
- Brooksville
- State
- FL
- Postal Code
- 34604
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2023-04-06 |
Proprietary Names
JAWS Nitinol Staple System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)