MedtechSourcebook

STRUCTURE MEDICAL, LLC.

Contract manufacturer · Naples, FL

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

FDA registration
3006783837 (openFDA record; or search FDA's registration database)
FEI number
3009322142
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
Structure Medical, LLC. (FDA owner/operator no. 10042434)
Registered address
9935 Business Circle, Naples, FL 34112
Contract listings
145 device listings, 46 product codes, first listed Nov 27, 2012
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
ETNStimulator, NerveClass IIEar, nose and throatContract manufacturingFeb 1, 2026
GWFStimulator, Electrical, Evoked ResponseClass IINeurologyContract manufacturingFeb 1, 2026
HAWNeurological Stereotaxic InstrumentClass IINeurologyContract manufacturingFeb 1, 2026
HRSPlate, Fixation, BoneClass IIOrthopedicContract manufacturingJan 15, 2013
HSBRod, Fixation, Intramedullary And AccessoriesClass IIOrthopedicContract manufacturingJan 16, 2013
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerClass IIOrthopedicContract manufacturingMar 25, 2020
HTNWasher, Bolt NutClass IIOrthopedicContract manufacturingFeb 1, 2013
HTYPin, Fixation, SmoothClass IIOrthopedicContract manufacturingJan 16, 2013
HWCScrew, Fixation, BoneClass IIOrthopedicContract manufacturingJan 15, 2013
HWNInstrument, CompressionClass IOrthopedicContract manufacturingSep 3, 2020
HWTTemplateClass IOrthopedicContract manufacturingNov 27, 2012
IKNElectromyograph, DiagnosticClass IIPhysical medicineContract manufacturingFeb 1, 2026
JDODevice, Fixation, Proximal Femoral, ImplantClass IIOrthopedicContract manufacturingJul 25, 2014
JDRStaple, Fixation, BoneClass IIOrthopedicContract manufacturingFeb 1, 2013
JDSNail, Fixation, BoneClass IIOrthopedicContract manufacturingFeb 1, 2026
JDWPin, Fixation, ThreadedClass IIOrthopedicContract manufacturingMar 25, 2020
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesClass IIGeneral hospitalContract manufacturingFeb 1, 2026
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentClass IIOrthopedicContract manufacturingFeb 1, 2013
KWIProsthesis, Elbow, Hemi-, Radial, PolymerClass IIOrthopedicContract manufacturingJan 16, 2013
KWPAppliance, Fixation, Spinal InterlaminalClass IIOrthopedicContract manufacturingJan 15, 2013
KWQAppliance, Fixation, Spinal Intervertebral BodyClass IIOrthopedicContract manufacturingJan 15, 2013
KYIProsthesis, Wrist, Carpal TrapeziumClass IIOrthopedicContract manufacturingJan 16, 2013
LXHOrthopedic Manual Surgical InstrumentClass IOrthopedicContract manufacturingDec 29, 2018
LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeClass IIOrthopedicContract manufacturingJan 16, 2013
MAXIntervertebral Fusion Device With Bone Graft, LumbarClass IIOrthopedicContract manufacturingJan 15, 2013
MBIFastener, Fixation, Nondegradable, Soft TissueClass IIOrthopedicContract manufacturingFeb 1, 2013
MNHOrthosis, Spondylolisthesis Spinal FixationClass IIOrthopedicContract manufacturingJan 15, 2013
MNIOrthosis, Spinal Pedicle FixationClass IIOrthopedicContract manufacturingJan 15, 2013
MQPSpinal Vertebral Body Replacement DeviceClass IIOrthopedicContract manufacturingJan 15, 2013
NKBThoracolumbosacral Pedicle Screw SystemClass IIOrthopedicContract manufacturingJan 15, 2013
NKGPosterior Cervical Screw SystemClass IIOrthopedicContract manufacturingFeb 1, 2026
NQOProsthesis, Spinous Process Spacer/PlateClass IIIOrthopedicContract manufacturingMar 30, 2019
NQWOrthosis, Spine, Plate, Laminoplasty, MetalClass IIOrthopedicContract manufacturingJan 15, 2013
OBTPlate, Bone, Growth Control, Pediatric, EpiphysiodesisClass IIOrthopedicContract manufacturingJan 15, 2013
ODPIntervertebral Fusion Device With Bone Graft, CervicalClass IIOrthopedicContract manufacturingJan 15, 2013
OLOOrthopedic Stereotaxic InstrumentClass IINeurologyContract manufacturingFeb 1, 2026
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisClass IIOrthopedicContract manufacturingJan 16, 2013
OURSacroiliac Joint FixationClass IIOrthopedicContract manufacturingFeb 1, 2026
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarClass IIOrthopedicContract manufacturingJan 15, 2013
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalClass IIOrthopedicContract manufacturingJan 16, 2013
OWIBone Fixation Cerclage, SublaminarClass IIOrthopedicContract manufacturingSep 15, 2026
OZIInternal Hinged Elbow FixatorClass IIOrthopedicContract manufacturingAug 9, 2019
PDQNeurosurgical Nerve LocatorClass IIEar, nose and throatContract manufacturingFeb 1, 2026
PHMIntervertebral Fusion Device With Bone Graft, ThoracicClass IIOrthopedicContract manufacturingFeb 1, 2026
PLRSpinal Vertebral Body Replacement Device - CervicalClass IIOrthopedicContract manufacturingJan 30, 2026
PMLBone Cement, Posterior Screw AugmentationClass IIOrthopedicContract manufacturingDec 9, 2024

Other contract facilities of Structure Medical, LLC.