Contract manufacturerSEAWAY PLASTICS ENGINEERING, LLC (Brooksville, FL)FloridaGeneral and plastic surgeryOrthopedicClass IClass II
SEAWAY PLASTICS ENGINEERING, LLC
Contract manufacturer ยท Brooksville, FL
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3027071765 (openFDA record; or search FDA's registration database)
- FEI number
- 3027071765
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Seaway Plastics Engineering, LLC (FDA owner/operator no. 10087696)
- Registered address
- 16186 Flight Path Drive, Brooksville, FL 34604
- Contract listings
- 10 device listings, 6 product codes, first listed Mar 28, 2023
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| FZT | Cutter, Surgical | Class I | General and plastic surgery | Contract manufacturing | Jun 19, 2023 |
| FZX | Guide, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Mar 28, 2023 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jun 19, 2023 |
| JDR | Staple, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Apr 6, 2023 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Mar 28, 2023 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | Contract manufacturing | Apr 6, 2023 |