Contract manufacturerLISI MEDICAL REmmele (Big Lake, MN)MinnesotaGeneral and plastic surgeryGeneral hospitalOrthopedicGastroenterology and urologyClass IIClass IUnclassified
LISI MEDICAL REmmele
Contract manufacturer ยท Big Lake, MN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3009941480 (openFDA record; or search FDA's registration database)
- FEI number
- 3009941480
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Precera Medical Inc (FDA owner/operator no. 10094474)
- Registered address
- 17701 198th Ave NW, Big Lake, MN 55309
- Contract listings
- 53 device listings, 25 product codes, first listed Dec 2, 2025
- 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 |
|---|---|---|---|---|---|
| EZX | Mesh, Surgical, Metal | Class II | General and plastic surgery | Contract manufacturing | Dec 2, 2025 |
| GAG | Stapler, Surgical | Class II | General hospital | Contract manufacturing | Dec 2, 2025 |
| GDW | Staple, Implantable | Class II | General and plastic surgery | Contract manufacturing | Dec 2, 2025 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract manufacturing | Dec 2, 2025 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Dec 2, 2025 |
| HTD | Forceps | Class I | General and plastic surgery | Contract manufacturing | Dec 2, 2025 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Dec 2, 2025 |
| HWR | Driver, Prosthesis | Class I | Orthopedic | Contract manufacturing | Dec 2, 2025 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Dec 2, 2025 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract manufacturing | Dec 2, 2025 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | Dec 2, 2025 |
| LFL | Instrument, Ultrasonic Surgical | Unclassified | General and plastic surgery | Contract manufacturing | Dec 2, 2025 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract manufacturing | Dec 2, 2025 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract manufacturing | Dec 2, 2025 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract manufacturing | Dec 2, 2025 |
| MQP | Spinal Vertebral Body Replacement Device | Class II | Orthopedic | Contract manufacturing | Dec 2, 2025 |
| MRW | System, Facet Screw Spinal Device | Unclassified | Orthopedic | Contract manufacturing | Dec 2, 2025 |
| NAY | System, Surgical, Computer Controlled Instrument | Class II | Gastroenterology and urology | Contract manufacturing | Dec 2, 2025 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract manufacturing | Dec 2, 2025 |
| NKG | Posterior Cervical Screw System | Class II | Orthopedic | Contract manufacturing | Dec 2, 2025 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | Contract manufacturing | Dec 2, 2025 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Class II | Orthopedic | Contract manufacturing | Dec 2, 2025 |
| OUR | Sacroiliac Joint Fixation | Class II | Orthopedic | Contract manufacturing | Dec 2, 2025 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Class II | Orthopedic | Contract manufacturing | Dec 2, 2025 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | Class II | Orthopedic | Contract manufacturing | Dec 2, 2025 |