LISI MEDICAL REmmele

FDA Device Registration & Listing · Big Lake, MN, US · Registration 3009941480

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009941480
FEI Number
3009941480
Entity Name
LISI MEDICAL REmmele
City/State/Country
Big Lake, MN, US
Establishment Address
17701 198th Ave NW, Big Lake, MN 55309, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Precera Medical Inc (Owner Number: 10094474)
Owner / Operator Contact Address
17701 198th Ave NW, Big Lake, MN 55309, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-12-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-12-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-12-02
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2025-12-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-02
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2025-12-02
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-12-02
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2025-12-02
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2025-12-02
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2025-12-02
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2025-12-02
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2025-12-02
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2025-12-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-12-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-12-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-12-02
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2025-12-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-12-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-12-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-12-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-02
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2025-12-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-02
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2025-12-02
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2025-12-02
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2025-12-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-02
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2025-12-02
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-12-02
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2025-12-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-02
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2025-12-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-12-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-12-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-12-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-12-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-12-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-12-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-02
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2025-12-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-12-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-12-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-02
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-12-02
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-12-02
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-12-02
EZX Mesh, Surgical, Metal General, Plastic Surgery Class 2 878.3300 2025-12-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-12-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-12-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-12-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-12-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-12-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-12-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-12-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-12-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-12-02
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2025-12-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-12-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-12-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-12-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-12-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-12-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-12-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-02
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2025-12-02
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-12-02
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2025-12-02
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-12-02
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-12-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-12-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-12-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-12-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-12-02
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2025-12-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-02
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-12-02
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-12-02
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2025-12-02
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-12-02
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2025-12-02
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-12-02
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-12-02
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-12-02
GAG Stapler, Surgical General Hospital Class 2 878.4740 2025-12-02
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2025-12-02

Official Correspondent

Claire Brown

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Precera Medical Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3000203391 LISI MEDICAL Remmele Coon Rapids, MN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K163363 Surgtech, Inc. SurgTech Thoracolumbosacral (TLS) Posterior Fixation System 2017-04-05
K252461 Spinal Resources, Inc. Swedge™ Pedicle Screw Fixation System Bezier Rod 2026-01-13
K140696 Pioneer Surgical Technology, Inc. STREAMLINE TL SPINAL FIXATION SYSTEM 2014-04-10
K141398 Medicrea International SA PASS LP SPINAL SYSTEM 2015-01-09
K160980 Spineology, Inc. Threshold Pedicular Fixation System, Palisade Pedicular Fixation System 2016-05-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2013 Synthes USA HQ, Inc. 2
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009941480. Last updated year: 2026. Please use registration number 3009941480 when referencing this establishment in official correspondence.
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