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Data / Medical devices / United States / Incipio Devices

Incipio Devices: FDA-registered device maker in Huntington, IN, United States, 1 510(k) clearance

Incipio Devices is registered with the FDA (registration 3011015572) in Huntington, IN, United States. It lists 38 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 26, 2014. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Incipio Devices
FDA registration number
3011015572
Address
3650 West 200 North, Huntington, IN, United States, 46750
Owner or operator
Incipio Devices (10047511)
Roles
Contract manufacturer, Manufacturer
First device listed
September 26, 2014
Registered through
2026
Brand names listed
5901-6060 - ReUnion TSA - Single Handle Cannulated Centering Guide, Active Plate System, Augment Reamer Guide Inserter, Comprehensive Reverse, Comprehensive Reverse Prolong Highly Crosslinked Polyethylene Bearing +3mm Retentive Thickness 40mm Diameter, Comprehensive Reverse Vivacit-E Highly Crosslinked Polyethylene Bearing +3mm Thickness Diameter40mm Diameter, Comprehensive Reverse Highly Crosslinked Polyethylene Bearing +3mm Thickness Diameter40mm Diameter, Comprehensive Reverse Prolong Highly Crosslinked Polyethylene Bearing +3mm Retentive Thickness 36mm Diameter and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal InterlaminalKWP2Contract manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Contract manufactureraccessdata.fda.gov
AwlHWJ1Contract manufactureraccessdata.fda.gov
ClampHXD1Contract manufactureraccessdata.fda.gov
ExtractorHWB1Contract manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Contract manufactureraccessdata.fda.gov
Hammer, SurgicalFZY1Contract manufactureraccessdata.fda.gov
ImpactorHWA1Manufactureraccessdata.fda.gov
Neurological Stereotaxic InstrumentHAW2Contract manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufacturer, Manufactureraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Contract manufactureraccessdata.fda.gov
OsteotomeHWM1Contract manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Contract manufacturer, 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, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedLZO2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedJDI2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerKRO2Contract 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 + Additive, CementedPAO2Contract manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedKWS2Contract manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedMBF2Contract manufactureraccessdata.fda.gov
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-ConstrainedPKC2Contract manufactureraccessdata.fda.gov
ReamerHTO1Contract manufacturer, Manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract manufacturer, Manufactureraccessdata.fda.gov
ScrewdriverHXX1Contract manufactureraccessdata.fda.gov
Shoulder Prosthesis, Reverse ConfigurationPHX2Contract manufactureraccessdata.fda.gov
Tap, BoneHWX1Contract manufactureraccessdata.fda.gov
TemplateHWT1Contract manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Contract 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
November 26, 2014K142938G3 Active Plate Large Fragment SystemHRSSubstantially EquivalentGenesis Fracture Care, Inc.accessdata.fda.gov

Compare with other makers

Updated November 26, 2014. 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.