Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000517406

FEI Number

1000517406

Entity Name

Paragon Medical Inc.

City/State/Country

Smithfield, UT, US

Establishment Address

125 W 1000 S, Smithfield, UT 84335, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Paragon Medical (Owner Number: 9011072)

Owner / Operator Contact Address

8 Matchett Dr., --, Pierceton, IN 46562, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 Zimmer Biomet Zimmer Biomet 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 Zimmer Biomet 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 Zimmer Biomet Fluted Pin Various Drills for Foot Surgery (Twist Drill, Over-Drill, Drill Bit) Universal Pin PERI-LOC IMN Instruments 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 TRIGEN 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 EXPEDIUM VERSE DRIVER - SLEEVE TriALTIS Navigation Enabled Instruments TriALTIS Navigation Enabled Instruments EXPEDIUM VERSE DRIVER - SLEEVE Signature

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWA	Impactor	Orthopedic	Class 1	888.4540	2013-01-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-12-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-12-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-01-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-01-18
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	Orthopedic	Class 2	888.3030	2013-01-18
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-01-18
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2020-06-15
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2025-11-24
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2023-08-03
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2013-01-18
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2013-01-20
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2020-06-16
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-04-01
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-01-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-01-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2016-08-25
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2016-08-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2016-08-25
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2017-06-05
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2022-05-11
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2025-12-05
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-12-05
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2017-02-16
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-11-24
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-11-24
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-11-24
HWD	Starter, Bone Screw	Orthopedic	Class 1	888.4540	2013-01-31
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-17
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-17
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-17
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2020-05-20
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2023-08-11
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-01-30
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-12-05
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-12-05
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-12-05
HWT	Template	Orthopedic	Class 1	888.4800	2013-01-20
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-12-05
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2013-01-18
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2013-01-18
KRQ	Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3550	2013-01-18
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2013-01-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-01-18
NPJ	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-01-18
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2013-01-18
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2013-01-18
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-06-16
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2013-01-31
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-01-17
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-11-24
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2025-11-24
HWB	Extractor	Orthopedic	Class 1	888.4540	2013-01-30
HTO	Reamer	Orthopedic	Class 1	888.4540	2013-01-17
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2025-11-24
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-11-24
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3660	2022-05-11
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2022-05-11
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2022-05-11
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2022-05-11
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2022-05-11
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	2013-01-30
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2013-01-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-01-17
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2013-01-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-01-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-01-18
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2015-10-26
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2015-10-26
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2025-12-05
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-12-05
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-12-05
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-12-05
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-12-05
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-12-05
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2024-11-05
HTO	Reamer	Orthopedic	Class 1	888.4540	2024-11-05
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-12-05
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-12-05
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-12-05
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-12-05
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-12-05
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2025-12-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-06-15
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2007-12-28
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2025-11-24
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2025-12-05
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-12-05
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2008-10-14
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2013-01-30
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2015-01-27
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-06-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-10-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-10-18
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2022-09-07
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3660	2022-09-07
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2022-09-07
HWJ	Awl	Orthopedic	Class 1	888.4540	2008-10-14
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2013-01-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-18
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2020-06-16
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-01-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-09-15
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2015-05-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-01-18
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2013-01-30
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2024-11-05
HTO	Reamer	Orthopedic	Class 1	888.4540	2024-11-05
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-09-13
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2013-01-17
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-01-17
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-12-18
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2024-11-05
HTO	Reamer	Orthopedic	Class 1	888.4540	2024-11-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-01-18
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-01-18
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	Orthopedic	Class 2	888.3030	2013-01-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-01-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-11-24
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-17
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-17
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-17
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-05-01
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2025-12-05
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-12-05
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-12-05
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-12-05

Official Correspondent

Stephane Langlois

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Paragon Medical

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009141957	AMETEK Poland sp. z o.o.	Siechnice Dolnoslaskie, PL
1834331	PARAGON MEDICAL, INC.	PIERCETON, IN, US
3007539489	Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou Jiangsu, CN
1835831	Paragon Medical Inc.	Castleton, IN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27
K972722	Orthopedic Designs, Inc.	ULTIMATE COMPRESSION SCREW SYSTEM	1998-01-23
K192974	Tyber Medical, LLC	Tyber Medical Trauma Screw	2020-01-08
K082949	OrthoPediatrics Corp.	ORTHOPEDIATRICS BONE SCREWS	2008-11-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2008	N/A	1	EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

Similar Registrations

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3023449169	BEIJING ROSSUMROBOT TECHNOLOGY CO., LTD.	Beijing, CN
3015542154	Zimmer Biomet Korea Ltd.	Seoul, KR
1221934	DePuy Mitek, Inc.	RAYNHAM, MA, US
3010536692	MICROPORT ORTHOPEDICS INC.	Arlington, TN, US
3010041511	Teleflex LLC (NADC)	Olive Branch, MS, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000517406. Last updated year: 2026. Please use registration number 1000517406 when referencing this establishment in official correspondence.