MedtechSourcebook

LISI MEDICAL Remmele

Contract manufacturer · Coon Rapids, MN

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
3000203391 (openFDA record; or search FDA's registration database)
FEI number
3000203391
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
Precera Medical Inc (FDA owner/operator no. 10094474)
Registered address
441 93rd Ave NW, Coon Rapids, MN 55433
Contract listings
35 device listings, 21 product codes, first listed Dec 5, 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 codeDevice (FDA name)ClassCategoryRoleFirst listed
DZADrill, Dental, IntraoralClass IDentalContract manufacturingDec 5, 2025
DZEImplant, Endosseous, Root-FormClass IIDentalContract manufacturingDec 5, 2025
GFCDriver, Surgical, PinClass IGeneral and plastic surgeryContract manufacturingDec 5, 2025
GZLElectrode, DepthClass IINeurologyContract manufacturingDec 5, 2025
HWCScrew, Fixation, BoneClass IIOrthopedicContract manufacturingDec 5, 2025
JDRStaple, Fixation, BoneClass IIOrthopedicContract manufacturingDec 5, 2025
KWPAppliance, Fixation, Spinal InterlaminalClass IIOrthopedicContract manufacturingDec 5, 2025
KWQAppliance, Fixation, Spinal Intervertebral BodyClass IIOrthopedicContract manufacturingDec 5, 2025
LXHOrthopedic Manual Surgical InstrumentClass IOrthopedicContract manufacturingDec 5, 2025
MAXIntervertebral Fusion Device With Bone Graft, LumbarClass IIOrthopedicContract manufacturingDec 5, 2025
MBIFastener, Fixation, Nondegradable, Soft TissueClass IIOrthopedicContract manufacturingDec 5, 2025
MNHOrthosis, Spondylolisthesis Spinal FixationClass IIOrthopedicContract manufacturingDec 5, 2025
MNIOrthosis, Spinal Pedicle FixationClass IIOrthopedicContract manufacturingDec 5, 2025
MRWSystem, Facet Screw Spinal DeviceUnclassifiedOrthopedicContract manufacturingDec 5, 2025
NDPAccessories, Implant, Dental, EndosseousClass IDentalContract manufacturingDec 5, 2025
NHAAbutment, Implant, Dental, EndosseousClass IIDentalContract manufacturingDec 5, 2025
NKBThoracolumbosacral Pedicle Screw SystemClass IIOrthopedicContract manufacturingDec 5, 2025
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisClass IIOrthopedicContract manufacturingDec 5, 2025
OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or TransobturatorClass IIGeneral and plastic surgeryContract manufacturingDec 5, 2025
OURSacroiliac Joint FixationClass IIOrthopedicContract manufacturingDec 5, 2025
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalClass IIOrthopedicContract manufacturingDec 5, 2025

Other contract facilities of Precera Medical Inc