FDA Registration
Active
🇺🇸 United States
LISI MEDICAL Remmele
Reg #: 3000203391
·
FEI: 3000203391
·
Expires 2026
Products
21
Proprietary Names
34
Establishment Types
1
Classifications
21
Registration Details
- Registration Name
- LISI MEDICAL Remmele
- Registration Number
- 3000203391
- FEI Number
- 3000203391
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 441 93rd Ave NW
- City
- Coon Rapids
- State
- MN
- ZIP
- 55433
- Country
- US
Owner / Operator
- Firm Name
- Precera Medical Inc
- Operator Number
- 10094474
- Address
- 17701 198th Ave NW
- City
- Big Lake
- State
- MN
- Postal Code
- 55309
- Country
- US
- Correspondent
- Claire E Brown
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-12-05 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-12-05 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2025-12-05 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2025-12-05 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2025-12-05 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2025-12-05 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2025-12-05 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2025-12-05 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2025-12-05 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2025-12-05 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2025-12-05 |
| Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | OTN | Class 2 | General, Plastic Surgery | No | 2025-12-05 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2025-12-05 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2025-12-05 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2025-12-05 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2025-12-05 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2025-12-05 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2025-12-05 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2025-12-05 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2025-12-05 |
| Electrode, Depth | GZL | Class 2 | Neurology | No | 2025-12-05 |
Proprietary Names
Asfora Bullet Cage® (System)
Fixation screw
Trinica & Trinica Select
inViZiaTrinica
Trinica ALP
V2F PLTE
Modular Polyaxial Tulip
InViZia (Anterior Cervical Plate Sys)
TRINICA IMP PLATE CERVICAL NS
Arsenal
ALP, SRW FXD TRINICA
CURVED ROD PKGED ST360
PIN INTERNAL INSERTION DISPOSABLE TRINICA
ArcTV Transvaginal Sling System
ArcSP Suprapubic Sling System
ROOK, OCC. SCREW
Kodiak
SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
Thoracolumbosacral pedicle screw system
Appliance, fixation, spinal intervertebral body
APPLIANCE, FIXATION
CNNLTD PLYSCRW
Spline Dental Implant System
Screw-Vent Dental Implant System
FACET screw
Zimmer Contour Restorative System
Surgical Drill System
SAMBA Screw (System)
Insignia Screw
Interfixated Screw
ELECTRODE, DEPTH
NUT LOCKING TRANS CONN SILH
Insignia
ARSENAL SPINAL FIXATION SYSTEM
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)