MedtechSourcebook

Paragon Medical - Dayton

Contract manufacturer · Dayton, OH

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

FDA registration
1000200989 (openFDA record; or search FDA's registration database)
FEI number
1000200989
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
Paragon Medical Inc. (FDA owner/operator no. 10043017)
Registered address
4201 Little York Rd, Dayton, OH 45414
Contract listings
41 device listings, 37 product codes, first listed Jan 18, 2013
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 manufacturingJan 29, 2013
FZXGuide, Surgical, InstrumentClass IGeneral and plastic surgeryContract manufacturingDec 30, 2013
HBBMotor, Drill, PneumaticClass IINeurologyContract manufacturingSep 26, 2017
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedClass IIOrthopedicContract manufacturingMay 13, 2022
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerClass IIOrthopedicContract manufacturingJan 29, 2019
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerClass IIOrthopedicContract manufacturingJan 12, 2022
HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/AttachmentClass IGeneral and plastic surgeryContract manufacturingSep 26, 2017
HTQBroachClass IOrthopedicContract manufacturingDec 30, 2013
HWDStarter, Bone ScrewClass IOrthopedicContract manufacturingJan 18, 2013
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentClass IGeneral and plastic surgeryContract manufacturingDec 11, 2021
HWTTemplateClass IOrthopedicContract manufacturingNov 5, 2018
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedClass IIOrthopedicContract manufacturingDec 30, 2013
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerClass IIOrthopedicContract manufacturingJan 5, 2015
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerClass IIOrthopedicContract manufacturingJun 22, 2018
KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/PolymerClass IIOrthopedicContract manufacturingJun 22, 2018
KWPAppliance, Fixation, Spinal InterlaminalClass IIOrthopedicContract manufacturingJan 29, 2013
KWQAppliance, Fixation, Spinal Intervertebral BodyClass IIOrthopedicContract manufacturingJan 29, 2013
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedClass IIOrthopedicContract manufacturingMay 13, 2022
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedClass IIOrthopedicContract manufacturingMay 13, 2022
LXHOrthopedic Manual Surgical InstrumentClass IOrthopedicContract manufacturingJan 29, 2013
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedClass IIOrthopedicContract manufacturingDec 30, 2013
MAXIntervertebral Fusion Device With Bone Graft, LumbarClass IIOrthopedicContract manufacturingSep 26, 2017
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedClass IIOrthopedicContract manufacturingMay 13, 2022
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerClass IIOrthopedicContract manufacturingJun 22, 2018
MJOProsthesis, Intervertebral DiscClass IIIOrthopedicContract manufacturingApr 26, 2016
MNHOrthosis, Spondylolisthesis Spinal FixationClass IIOrthopedicContract manufacturingJan 29, 2013
MNIOrthosis, Spinal Pedicle FixationClass IIOrthopedicContract manufacturingJan 29, 2013
MQPSpinal Vertebral Body Replacement DeviceClass IIOrthopedicContract manufacturingJan 29, 2013
MRWSystem, Facet Screw Spinal DeviceUnclassifiedOrthopedicContract manufacturingJan 22, 2013
NKBThoracolumbosacral Pedicle Screw SystemClass IIOrthopedicContract manufacturingJan 29, 2013
NQWOrthosis, Spine, Plate, Laminoplasty, MetalClass IIOrthopedicContract manufacturingJan 29, 2013
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveClass IIOrthopedicContract manufacturingNov 25, 2019
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarClass IIOrthopedicContract manufacturingSep 26, 2017
PAOProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, CementedClass IIOrthopedicContract manufacturingMay 13, 2022
PHMIntervertebral Fusion Device With Bone Graft, ThoracicClass IIOrthopedicContract manufacturingSep 26, 2017
PHXShoulder Prosthesis, Reverse ConfigurationClass IIOrthopedicContract manufacturingMay 13, 2022
PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-ConstrainedClass IIOrthopedicContract manufacturingMay 13, 2022