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Data / Medical devices / United States / Paragon Medical, Inc.

Paragon Medical, Inc.: FDA-registered device maker in Pierceton, IN, United States, 4 510(k) clearances

Paragon Medical, Inc. is registered with the FDA (registration 1834331) in Pierceton, IN, United States. It lists 114 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 13, 2019. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Paragon Medical, Inc.
FDA registration number
1834331
FEI number
1000306340
Address
8 Matchett Dr., Pierceton, IN, United States, 46562
Owner or operator
Paragon Medical (9011072)
Roles
Contract manufacturer, Manufacturer
First device listed
July 27, 1994
Registered through
2026
Brand names listed
"Insertion Sleeve for ø3.2mm Guide Wires", 2 FRAGMENT PLATE BENDER, 2 FRAGMENT PLATE BENDER END, 36MM POLY LINER PLUS 3MM OFS, 3MM DRILL BIT, LONG, A.L.P.S. Clavicle Plating System, AGILE NAIL STERILIZATION BOX EMPTY, AGILE NAIL STERILIZATION BOX EXTRACTION EMPTY and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Contract manufactureraccessdata.fda.gov
Accessories, Implant, Dental, EndosseousNDP1Contract manufactureraccessdata.fda.gov
Apparatus, Traction, Non-PoweredHST1Contract manufactureraccessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT2Contract manufactureraccessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeLXT2Contract manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal InterlaminalKWP2Contract manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Contract manufactureraccessdata.fda.gov
ArthroscopeHRX2Contract manufactureraccessdata.fda.gov
AwlHWJ1Contract manufactureraccessdata.fda.gov
Bit, DrillHTW1Contract manufactureraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Contract manufactureraccessdata.fda.gov
Bone Cement, Posterior Screw AugmentationPML2Contract manufactureraccessdata.fda.gov
Bone MillLYS1Contract manufactureraccessdata.fda.gov
BroachHTQ1Contract manufactureraccessdata.fda.gov
Cerclage, FixationJDQ2Contract manufactureraccessdata.fda.gov
ClampHXD1Contract manufactureraccessdata.fda.gov
Cutter, SurgicalFZT1Contract manufactureraccessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceERL2Contract manufactureraccessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Simple, Powered)HBE2Contract manufactureraccessdata.fda.gov
Driver, ProsthesisHWR1Contract manufactureraccessdata.fda.gov
ExtractorHWB1Contract manufactureraccessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft TissueMAI2Contract manufactureraccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Contract manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Contract manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Contract manufactureraccessdata.fda.gov
ImpactorHWA1Contract manufactureraccessdata.fda.gov
Instrument, Bending Or ContouringHXP1Contract manufactureraccessdata.fda.gov
Instrument, Cutting, OrthopedicHTZ1Contract manufactureraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Contract manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Contract manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Contract manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/AttachmentKIJ1Contract manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/AttachmentHSZ1Contract manufactureraccessdata.fda.gov
Instruments Designed For Press-Fit Osteochondral ImplantsQBO2Contract 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 Integrated Fixation, CervicalOVE2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Contract manufactureraccessdata.fda.gov
Mesh, Surgical, Acetabular, Hip, ProsthesisJDJ2Contract manufactureraccessdata.fda.gov
Motor, Drill, ElectricHBC2Contract manufactureraccessdata.fda.gov
Motor, Drill, PneumaticHBB2Contract manufactureraccessdata.fda.gov
Motor, Surgical Instrument, Ac-PoweredGEY1Contract manufactureraccessdata.fda.gov
Nail, Fixation, BoneJDS2Contract manufactureraccessdata.fda.gov
Neurological Stereotaxic InstrumentHAW2Contract 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
Pin, Fixation, SmoothHTY2Contract manufactureraccessdata.fda.gov
Pin, Fixation, Smooth, MetallicNDL2Contract manufactureraccessdata.fda.gov
Plate, Bone, Growth Control, Pediatric, EpiphysiodesisOBT2Contract manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic FinishMAY2Contract manufactureraccessdata.fda.gov
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerHSN2Contract manufactureraccessdata.fda.gov
Prosthesis, Elbow, Constrained, CementedJDC2Contract manufactureraccessdata.fda.gov
Prosthesis, Elbow, Hemi-, Radial, PolymerKWI2Contract manufactureraccessdata.fda.gov
Prosthesis, Elbow, Semi-Constrained, CementedJDB2Contract manufactureraccessdata.fda.gov
Prosthesis, Finger, Constrained, Metal/PolymerKWG3Contract manufactureraccessdata.fda.gov
Prosthesis, Finger, Constrained, PolymerKYJ2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerKWZ2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Femoral Component, Cemented, MetalJDG2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, MetalKWL2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal BallLZY2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedKWY2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedLZO2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Metal, ResurfacingNXT3Contract 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, Hip, Semi-Constrained, Metal/Polymer, UncementedLWJ2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateMEH2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousMBL2Contract manufactureraccessdata.fda.gov
Prosthesis, Intervertebral DiscMJO3Contract manufactureraccessdata.fda.gov
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/PolymerNPJ2Contract 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, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerHRY2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/PolymerKRR2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/PolymerKRQ2Contract 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, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile BearingNJL3Contract 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
Prosthesis, Wrist, Hemi-, UlnarKXE2Contract manufactureraccessdata.fda.gov
Punch, SurgicalLRY1Contract manufactureraccessdata.fda.gov
RaspHTR1Contract manufactureraccessdata.fda.gov
ReamerHTO1Contract manufactureraccessdata.fda.gov
RetractorGAD1Contract manufactureraccessdata.fda.gov
Retractor, Self-Retaining, For NeurosurgeryGZT2Contract manufactureraccessdata.fda.gov
Rod, Fixation, Intramedullary And AccessoriesHSB2Contract manufactureraccessdata.fda.gov
Saw, Pneumatically PoweredKFK1Contract manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract manufactureraccessdata.fda.gov
ScrewdriverHXX1Contract manufactureraccessdata.fda.gov
Semi-Constrained Metal/Polymer Finger Joint ProsthesisMPKfContract manufactureraccessdata.fda.gov
Shoulder Prosthesis, Reverse ConfigurationPHX2Contract manufactureraccessdata.fda.gov
Software For Diagnosis/TreatmentOSN2Contract manufactureraccessdata.fda.gov
Spinal Vertebral Body Replacement DeviceMQP2Contract manufactureraccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Contract manufacturer, Manufactureraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Contract manufactureraccessdata.fda.gov
TampHXG1Contract manufactureraccessdata.fda.gov
Tap, BoneHWX1Contract manufactureraccessdata.fda.gov
TemplateHWT1Contract manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Contract manufactureraccessdata.fda.gov
Tray, SurgicalLRP1Contract manufactureraccessdata.fda.gov
Tray, Surgical, EntMMO1Contract manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Contract 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
June 13, 2019K190667Sonopet iQ Sterilization TrayKCTSubstantially EquivalentParagon Medicalaccessdata.fda.gov
May 7, 2019K183701Stryker ChestShield Sterilization Tray SystemKCTSubstantially EquivalentParagon Medicalaccessdata.fda.gov
April 18, 2018K173615Stryker Universal Select Sterilization Tray SystemKCTSubstantially EquivalentParagon Medicalaccessdata.fda.gov
December 28, 2015K152951Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization TrayKCTSubstantially EquivalentParagon Medical, Inc.accessdata.fda.gov

Compare with other makers

Updated June 13, 2019. 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.