FDA Registration
Active
🇺🇸 United States
LISI MEDICAL REmmele
Reg #: 3009941480
·
FEI: 3009941480
·
Expires 2026
Products
25
Proprietary Names
61
Establishment Types
1
Classifications
25
Registration Details
- Registration Name
- LISI MEDICAL REmmele
- Registration Number
- 3009941480
- FEI Number
- 3009941480
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 17701 198th Ave NW
- City
- Big Lake
- State
- MN
- ZIP
- 55309
- 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 |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2025-12-02 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2025-12-02 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2025-12-02 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2025-12-02 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2025-12-02 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2025-12-02 |
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2025-12-02 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-12-02 |
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2025-12-02 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2025-12-02 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2025-12-02 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2025-12-02 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2025-12-02 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2025-12-02 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2025-12-02 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2025-12-02 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2025-12-02 |
| Mesh, Surgical, Metal | EZX | Class 2 | General, Plastic Surgery | No | 2025-12-02 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2025-12-02 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2025-12-02 |
| Stapler, Surgical | GAG | Class 2 | General Hospital | No | 2025-12-02 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2025-12-02 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2025-12-02 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-12-02 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2025-12-02 |
Proprietary Names
EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM
Da Vinci Single-Site Instrument and Accessories
CONDUIT Lateral Switch Plate
System, surgical, computer controlled instrument
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2001
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000
DELTA XTEND Reverse Shoulder System
CTR METAGLENE SCREW
DELTA XTEND FLEXIBLE COLLET FULL THREADS
TTBlue, Accessory for HP Blue
ALPS
R2R
IS ILIAC SCW
IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps
IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Ins
IIEXP 55 SS CLS NARROW
IEXP 635 SS CLS HK
VIPER MONO SCREW
IEXP 635 SS SLOTTED CONN
IEXP DDV SS CLS BLT
IEXP SS NEST PLT
EXP 4.5 SS OP PED HK 3
EXP DI POLY SCREW
IEXP SS SMITH PLT
IEXP SS LOCK NUT BOLT
IEXP SS POLY BLT
IEXP SS FIX BLT RDX
IEXP SS PLY BLT RDX
IEXP SS SMITH
IEXP SS MCC PLATE
IEXP 635 SS SPLIT CONN
IEXP 55 SS OPN HK
IEXP 55 SS CLS HK WIDE
IEXP 635 SS ANGULATING CONN
IS4000 Stapler 30 Instrument and Stapler 30 Reloads
BENGAL STACKABLE CAGE SYSTEM
SYPMHONY OCT System
VIPER F2 FACET FIXATION SYSTEM
SI Set Screw
EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System
CONCORDE® Curve Lumbar Interbody System
CONCORDE® Inline Lumbar Interbody System
CONCORDE® Bullet Lumbar Interbody System
Stackable Cage System
X-MESH® Expandable Cage System
Surgical Titanium Mesh System
CONCORDE® System
OCELOT® Stackable Cage System
BENGAL System
EXPEDIUM SPINE SYSTEM
ActiveTM Anterior Cervical Plate System
EXPEDIUM Spine System/Synapse System
IS4000 da Vinci EndoWrist Instruments
Bengal Stackable Cage System
Expedium Spine System, VIPER and VIPER 2 Systems
SUMMIT Fixation System
MOUNTAINEER OCT Spinal System
SUMMIT SI OCT Spinal Fixation System
YMPHONY OCT System
HOOK
SureForm 45, SureForm 45 Reloads
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)