FDA Registration Active 🇺🇸 United States

Paragon Medical Inc.

Reg #: 1000517406 · FEI: 1000517406 · Expires 2026
Products
67
Proprietary Names
276
Establishment Types
1
Classifications
67

Registration Details

Registration Name
Paragon Medical Inc.
Registration Number
1000517406
FEI Number
1000517406
Status
Active
Expiry Year
2026
Initial Importer
No
Address
125 W 1000 S
City
Smithfield
State
UT
ZIP
84335
Country
US

Owner / Operator

Firm Name
Paragon Medical
Operator Number
9011072
Address
8 Matchett Dr., --
City
Pierceton
State
IN
Postal Code
46562
Country
US
Correspondent
Stephane Langlois

Products

Device Name Product Code
Impactor HWA
Screw, Fixation, Bone HWC
Plate, Fixation, Bone HRS
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
Pin, Fixation, Threaded JDW
Spinal Vertebral Body Replacement Device MQP
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
Driver, Prosthesis HWR
Appliance, Fixation, Spinal Intervertebral Body KWQ
Washer, Bolt Nut HTN
Mallet HXL
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
Posterior Cervical Screw System NKG
Appliance, Fixation, Spinal Interlaminal KWP
Instrument, Surgical, Non-Powered HAO
Intervertebral Fusion Device With Bone Graft, Cervical ODP
Intervertebral Fusion Device With Bone Graft, Lumbar MAX
Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
Starter, Bone Screw HWD
Orthosis, Spondylolisthesis Spinal Fixation MNH
Orthosis, Spinal Pedicle Fixation MNI
Cannula, Surgical, General & Plastic Surgery GEA
Thoracolumbosacral Pedicle Screw System NKB
Template HWT
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer KRQ
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer NPJ
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
Hammer, Surgical FZY
Dilator, Catheter GCC
Guide, Surgical, Instrument FZX
Extractor HWB
Reamer HTO
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
Bit, Surgical GFG
Retractor GAD
Pin, Fixation, Smooth HTY
Fastener, Fixation, Biodegradable, Soft Tissue MAI
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
Arthroscope HRX
Orthopedic Manual Surgical Instrument LXH
Bone Fixation Cerclage, Sublaminar OWI
Instrument, Manual, Surgical, General Use MDM
Bit, Drill HTW
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
Orthopedic Stereotaxic Instrument OLO
Shoulder Prosthesis, Reverse Configuration PHX
Awl HWJ
Rod, Fixation, Intramedullary And Accessories HSB
Elevator, Surgical, General & Plastic Surgery GEG
Accessories, Arthroscopic NBH
Instrument, Bending Or Contouring HXP
Tap, Bone HWX
Gauge, Depth HTJ
Screwdriver HXX
Applier, Staple, Surgical, GEF
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC

Proprietary Names

Zimmer Biomet PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 30MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 36MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 75MM SELF-TAPPING PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 75MM PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 16MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 70MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 62MM SELF-TAPPING PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 85MM PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 20MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 72MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 50MM SELF-TAPPING PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 35MM PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 66MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 52MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 76MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 36MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 85MM SELF-TAPPING 5.7MM CANN LCK SCRW 20MM PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 20MM PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 38MM SELF-TAPPING PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 25MM PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 50MM SELF-TAPPING PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 45MM PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 42MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 22MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 110MM SELF-TAPPING PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 70MM PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 95MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 68MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 56MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 26MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 65MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 24MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 22MM SELF-TAPPING PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 30MM PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 46MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 14MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 54MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 58MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 90MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 24MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 20MM SELF-TAPPING PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 65MM PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 55MM PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 30MM SELF-TAPPING PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 40MM PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 18MM SELF-TAPPING PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 50MM PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 90MM PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 48MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 32MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 38MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 18MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 55MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 78MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 40MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 26MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 14MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 34MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 90MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 80MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 10MM SELF-TAPPING PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 60MM PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 60MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 95MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 32MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 45MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 64MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 70MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 12MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 16MM SELF-TAPPING PERI-LOC 5.7MM TITANIUM CANNULATED LOCKING SCREW 80MM PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 44MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 28MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 100MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 28MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 40MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 74MM SELF-TAPPING PERI-LOC 3.5MM T20 TITANIUM CORTEX SCREW 34MM SELF-TAPPING PERI-LOC 4.5MM T25 TITANIUM CORTEX SCREW 60MM SELF-TAPPING JET-X Driver Half Pin T2 ICF System 5.7MM CANN LCK SCREW 120MM 5.7MM CANN LCK SCREW 85MM 5.7MM CANN LCK SCREW 40MM 5.7MM CANN LCK SCREW 50MM 5.7MM CANN LCK SCREW 45MM 5.7MM CANN LCK SCREW 65MM 5.7MM CANN LCK SCREW 25MM 5.7MM CANN LCK SCREW 110MM 5.7MM CANN LCK SCREW 55MM 5.7MM CANN LCK SCREW 75MM 5.7MM CANN LCK SCREW 80MM 5.7MM CANN LCK SCREW 35MM 5.7MM CANN LCK SCREW 115MM 5.7MM CANN LCK SCREW 105MM 5.7MM CANN LCK SCREW 95MM 5.7MM CANN LCK SCREW 60MM 5.7MM CANN LCK SCREW 100MM 5.7MM CANN LCK SCREW 30MM 5.7MM CANN LCK SCREW 70MM 5.7MM CANN LCK SCREW 90MM Mallet KEEL TIB PUNCH GUIDE SZ1.5-4 Tornier HRS Max LEGION Hammer AMBI TRIGEN POLYETHYLENE LINER EXTRACTOR DRIVE SHAFT REAMER DEPTH STOP 10/12MM GENESIS The GIRO Growth Modulation System Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe) REAMER DEPTH STOP 8/10MM A.L.P.S. Clavicle Plating System Clavicle Plating Instruments PERI-LOC Drill Sleeve Insert K-Wire Sleeve Insert Orthopedic Manual Surgical Instrument LITe Funnel Bone Tap Freehand Drill IMN Instruments ø4.2x185mm Locking Drill IMN Instruments ø4.2x360mm Trocar SPS-MonoAxial Locking Set 5mm Inserter sleeve Freehand Drill IMN Instruments ø3.5x130mm Drill Sleeve D4.3 "Insertion Sleeve for ø3.2mm Guide Wires" Depth Gauge 0-120mm Insert ø3.2 compression Guide Wire D3xL300 Trocar SPS-MonoAxial Locking Set 4mm Freehand Drill IMN Instruments ø3.5x185mm Drill Guide ø6.55 Drilling Guide ø3.2/4.5 Locking Drill IMN Instruments ø3.5x360mm Depth Gauge 0-70mm for Screws: ø2.7/3.5/4mm Freehand Drill IMN Instruments ø4.2x130mm Insert ø2.5 compression Tissue prot. sleeve ø6.5/4.5 Threaded Guide Wire D3.2xL300 (Sterile) Screw Insertion Sleeve ø9mm Lag Screw Tap Sleeve Drilling Guide ø2.5/3.5 Parallel Drill Guide Insert ø2.5 neutral Drill Sleeve Handle Direct Measuring Gauge Depth Gauge 0-150mm for Screws: ø4.5/6.5mm Drill Guide Supracondylar Lag Screw Depth Gauge Drill Sleeve D3.1 Depth Gauge 0-110mm For Screws ø2.7/3.5/4 Depth Gauge 0-150mm for Screws: ø2.7/3.5/4mm Insert ø2.5 support Drilling Guide ø2/2.7 Drill Gauge (Percutaneous) Guide Wire D3.2xL300 Threaded Guide Wire D3.2xL300 Guide Wire with Ruler Tube Insert ø3.2 neutral Guide Wire D3.2xL300 (Sterile) Distractor Twist Drill Centerpiece Plate Fixation System C-STEM AMT SZ 3A NK SEGMENT IMN™ Instruments C-STEM AMT STD NECK SEGMENT- SZ0/1 INSERTION SHIM - HANDLE Guide Wire C-STEM AMT SZ 2A NK SEGMENT C-STEM AMT HO NECK SEGMENT- SZ4/5 C-STEM AMT HO NECK SEGMENT- SZ 0/1 C-STEM AMT HO NECK SEGMENT- SZ2/3 C-STEM AMT STD NECK SEGMENT- SZ2/3 C-STEM AMT STD NECK SEGMENT- SZ6/7 Fluted Pin Various Drills for Foot Surgery (Twist Drill, Over-Drill, Drill Bit) Universal Pin Drill Bit, AO EXPEDIUM VERSE DRIVER - SLEEVE 6.5 FULLY THREADED CANCELLOUS SCREW 35MM 6.5 16MM THREAD CANCELLOUS SCREW 145MM 6.5 16MM THREAD CANCELLOUS SCREW 100MM 6.5 16MM THREAD CANCELLOUS SCREW 65MM 6.5 FULLY THREADED CANCELLOUS SCREW 125MM CANNULATED HIP PIN 120MM 6.5 16MM THREAD CANCELLOUS SCREW 80MM 6.5 FULLY THREADED CANCELLOUS SCREW 95MM CANNULATED HIP PIN 110MM 6.5 FULLY THREADED CANCELLOUS SCREW 80MM 6.5 16MM THREAD CANCELLOUS SCREW 115MM 6.5 FULLY THREADED CANCELLOUS SCREW 140MM CANNULATED HIP PIN 70MM CANNULATED HIP PIN 30MM CANNULATED HIP PIN 90MM CANNULATED HIP PIN 125MM 6.5 16MM THREAD CANCELLOUS SCREW 110MM CANNULATED HIP PIN 65MM 6.5 16MM THREAD CANCELLOUS SCREW 85MM 6.5 FULLY THREADED CANCELLOUS SCREW 70MM 6.5 FULLY THREADED CANCELLOUS SCREW 100MM CANNULATED HIP PIN 105MM CANNULATED HIP PIN 50MM 6.5 FULLY THREADED CANCELLOUS SCREW 50MM 6.5 16MM THREAD CANCELLOUS SCREW 130MM 6.5 FULLY THREADED CANCELLOUS SCREW 75MM 6.5 FULLY THREADED CANCELLOUS SCREW 115MM 6.5 16MM THREAD CANCELLOUS SCREW 75MM 6.5 16MM THREAD CANCELLOUS SCREW 135MM 6.5 FULLY THREADED CANCELLOUS SCREW 110MM CANNULATED HIP PIN 135MM 6.5 FULLY THREADED CANCELLOUS SCREW 65MM CANNULATED HIP PIN 115MM 6.5 FULLY THREADED CANCELLOUS SCREW 60MM 6.5 FULLY THREADED CANCELLOUS SCREW 120MM CANNULATED HIP PIN 35MM CANNULATED HIP PIN 85MM 6.5 FULLY THREADED CANCELLOUS SCREW 45MM 6.5 16MM THREAD CANCELLOUS SCREW 70MM 6.5 16MM THREAD CANCELLOUS SCREW 45MM CANNULATED HIP PIN 60MM 6.5 FULLY THREADED CANCELLOUS SCREW 130MM 6.5 16MM THREAD CANCELLOUS SCREW 90MM 6.5 FULLY THREADED CANCELLOUS SCREW 150MM CANNULATED HIP PIN 95MM CANNULATED HIP PIN 75MM 6.5 16MM THREAD CANCELLOUS SCREW 55MM 6.5 16MM THREAD CANCELLOUS SCREW 30MM 6.5 16MM THREAD CANCELLOUS SCREW 60MM 6.5 16MM THREAD CANCELLOUS SCREW 40MM CANNULATED HIP PIN 100MM 6.5 16MM THREAD CANCELLOUS SCREW 125MM 6.5 FULLY THREADED CANCELLOUS SCREW 30MM 6.5 FULLY THREADED CANCELLOUS SCREW 40MM 6.5 FULLY THREADED CANCELLOUS SCREW 135MM CANNULATED HIP PIN 40MM 6.5 16MM THREAD CANCELLOUS SCREW 35MM 6.5 FULLY THREADED CANCELLOUS SCREW 145MM 6.5 16MM THREAD CANCELLOUS SCREW 50MM 6.5 16MM THREAD CANCELLOUS SCREW 120MM CANNULATED HIP PIN 130MM 6.5 16MM THREAD CANCELLOUS SCREW 150MM 6.5 FULLY THREADED CANCELLOUS SCREW 90MM 6.5 16MM THREAD CANCELLOUS SCREW 140MM 6.5 FULLY THREADED CANCELLOUS SCREW 105MM CANNULATED HIP PIN 55MM 6.5 FULLY THREADED CANCELLOUS SCREW 25MM CANNULATED HIP PIN 45MM 6.5 16MM THREAD CANCELLOUS SCREW 105MM 6.5 16MM THREAD CANCELLOUS SCREW 95MM 6.5 FULLY THREADED CANCELLOUS SCREW 55MM 6.5 FULLY THREADED CANCELLOUS SCREW 85MM CANNULATED HIP PIN 80MM Graft Sizer SharpShooter Cannula Right Middle SharpShooter Cannula Right Posterior CMI Delivery Clamp CMI Measuring Cannula SharpShooter Cannula Left Middle SharpShooter Cannula Right Anterior SharpShooter Cannula Left Anterior SharpShooter Cannula Left Posterior TriALTIS Navigation Enabled Instruments Signature 2 FRAGMENT PLATE BENDER END 2 FRAGMENT PLATE BENDER Intermediate Tap, Locking, AO Biomet Proximal Humerus Plating System Depth Gage Screwdriver

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)