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Data / Medical devices / United States / Complexus Medical

Complexus Medical: FDA-registered device maker in Mishawaka, IN, United States, 1 510(k) clearance

Complexus Medical is registered with the FDA (registration 3009887475) in Mishawaka, IN, United States. It lists 56 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 18, 2018. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Complexus Medical
FDA registration number
3009887475
Address
55980 Russell Industrial Pkwy, Mishawaka, IN, United States, 46545
Owner or operator
Complexus Medical (10042212)
Roles
Contract manufacturer, Manufacturer
First device listed
November 1, 2012
Registered through
2026
Brand names listed
14-510008-00 Coronal Bending Iron, Left - Biomet Spine, 14-510009-00 Coronal Bending Iron, Right - Biomet Spine, 14-531593-00 Drill / Awl Sleeve - Biomet Spine, 14-531594-00 Drill / Awl Spring Sleeve - Biomet Spine, 14-531702-00 Low Pro Awl - Biomet Spine, 180mm Carbon Rod, Blue Device, 2 Plate Hold on Cannula, Sm, 20-8020-037-00 Rosa Polyaxial Reference Size 3 and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT2Contract manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal InterlaminalKWP2Contract manufacturer, Manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Contract manufactureraccessdata.fda.gov
AwlHWJ1Contract manufactureraccessdata.fda.gov
BenderHXW1Contract manufactureraccessdata.fda.gov
BroachHTQ1Contract manufactureraccessdata.fda.gov
CaliperKTZ1Contract manufactureraccessdata.fda.gov
ClampHXD1Contract manufactureraccessdata.fda.gov
Device, Fixation, Proximal Femoral, ImplantJDO2Contract manufactureraccessdata.fda.gov
Device, Prosthesis AlignmentIQO1Contract manufactureraccessdata.fda.gov
External Mandibular Fixator And/Or DistractorMQN2Contract manufactureraccessdata.fda.gov
ExtractorHWB1Contract manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Contract manufactureraccessdata.fda.gov
Gauge, Depth, Instrument, DentalEIL1Contract manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Contract manufactureraccessdata.fda.gov
Hammer, SurgicalFZY1Contract manufactureraccessdata.fda.gov
Handle, Instrument, DentalEJB1Contract manufactureraccessdata.fda.gov
ImpactorHWA1Contract manufactureraccessdata.fda.gov
Instrument, Bending Or ContouringHXP1Contract manufactureraccessdata.fda.gov
Instrument, Cutting, OrthopedicHTZ1Contract manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, ThoracicPHM2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Contract manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufactureraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Contract manufactureraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Contract manufactureraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Contract manufactureraccessdata.fda.gov
OsteotomeHWM1Contract manufactureraccessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOSH2Contract manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Contract manufactureraccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Contract manufactureraccessdata.fda.gov
ProbeHXB1Contract manufactureraccessdata.fda.gov
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerHSN2Contract manufactureraccessdata.fda.gov
Prosthesis, Elbow, Constrained, CementedJDC2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerHSX2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerMBH2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOIY2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH2Contract manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Hemi-, Humeral, Metallic UncementedHSD2Contract manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer CementedKWT2Contract manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedKWS2Contract manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedMBF2Contract manufactureraccessdata.fda.gov
RetractorGAD1Contract manufactureraccessdata.fda.gov
ScrewdriverHXX1Contract manufactureraccessdata.fda.gov
Shoulder Prosthesis, Reverse ConfigurationPHX2Contract manufactureraccessdata.fda.gov
Spinal Vertebral Body Replacement DeviceMQP2Contract manufactureraccessdata.fda.gov
Spinal Vertebral Body Replacement Device - CervicalPLR2Contract manufactureraccessdata.fda.gov
TemplateHWT1Contract manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Contract manufacturer, Manufactureraccessdata.fda.gov
Tray, SurgicalLRP1Contract manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Contract manufactureraccessdata.fda.gov
Trocar, EntKTE1Contract manufactureraccessdata.fda.gov
WrenchHXC1Contract manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 18, 2018K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemNKBSubstantially EquivalentOrthoPediatrics Corp.accessdata.fda.gov

Compare with other makers

Updated September 18, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.