LISI MEDICAL Remmele

FDA Device Registration & Listing · Coon Rapids, MN, US · Registration 3000203391

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
3000203391
FEI Number
3000203391
Entity Name
LISI MEDICAL Remmele
City/State/Country
Coon Rapids, MN, US
Establishment Address
441 93rd Ave NW, Coon Rapids, MN 55433, 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

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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-12-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-12-05
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2025-12-05
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-12-05
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-05
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-12-05
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-12-05
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-12-05
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-05
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2025-12-05
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-12-05
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-05
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-12-05
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2025-12-05
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-05
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-05
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-12-05
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-12-05
GFC Driver, Surgical, Pin General, Plastic Surgery Class 1 878.4820 2025-12-05
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2025-12-05
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2025-12-05
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-12-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-12-05
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2025-12-05
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-05
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-05
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-05
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-12-05
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-12-05
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-05
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-05-07
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-05-07
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-05-07
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-05
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-12-05
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-12-05
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2025-12-05
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2025-12-05
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2025-12-05
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-12-05

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
3009941480 LISI MEDICAL REmmele Big Lake, MN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K223430 Life Spine, Inc. ProLift Micro Expandable Spacer System 2023-05-04
K102293 Globus Medical, Inc. CALIBER SPACER 2011-01-05
K193541 Nu Vasive, Incorporated NuVasive Cohere Thoracolumbar Interbody System 2020-03-30
K080401 Advanced Medical Technologies AG SHELL CAGE, WAVE CAGE, LOOP CAGE 2008-05-09
K200084 Zavation Medical Products, LLC Zavation IBF System 2020-10-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000203391. Last updated year: 2026. Please use registration number 3000203391 when referencing this establishment in official correspondence.
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