FDA Registration
Active
🇺🇸 United States
SEAWAY PLASTICS ENGINEERING, LLC
Reg #: 3027071765
·
FEI: 3027071765
·
Expires 2026
Products
6
Proprietary Names
9
Establishment Types
1
Classifications
6
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Registration Details
- Registration Name
- SEAWAY PLASTICS ENGINEERING, LLC
- Registration Number
- 3027071765
- FEI Number
- 3027071765
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 16186 Flight Path Drive
- City
- Brooksville
- State
- FL
- ZIP
- 34604
- Country
- US
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 |
|---|---|---|---|---|---|
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2023-03-28 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2023-04-06 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2023-04-06 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2023-03-28 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2023-06-19 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2023-06-19 |
Proprietary Names
Megalodon Dynamic Compression System
Grappler Suture Anchor System
Grappler Suture Anchor R3FLEX IOL System
TenoTac 2 Soft Tissue Fixation System; TenoTac Soft Tissue Fixation System
JAWS Nitinol Staple System
Paratrooper Plantar Plate Repair System
Tendon Harvester System
Grappler Interference Screw System
APEX 3D Total Ankle Replacement System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)