Paragon Medical Inc.

FDA Device Registration & Listing · Castleton, IN, US · Registration 1835831

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1835831
FEI Number
3001814066
Entity Name
Paragon Medical Inc.
City/State/Country
Castleton, IN, US
Establishment Address
7350 E. 86TH ST., Castleton, IN 46256, 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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

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 Driver M-M TI TRANSVERSE CONNECTOR SYMPHONY™ OCT System 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 KEEL TIB PUNCH GUIDE SZ1.5-4 Tornier HRS Max Z1 Hip System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-31
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2007-12-28
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2017-12-15
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2017-12-15
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2017-12-15
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-02-07
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
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2022-05-11
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 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
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
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-30
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-30
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-30
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2013-01-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-30
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-30
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-30
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2025-01-07
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-03-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-03-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-10-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-10-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-30
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-02-04
HWT Template Orthopedic Class 1 888.4800 2013-01-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-31
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2024-08-12
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2024-08-12
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2024-08-12
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2024-08-12
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2024-08-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-04-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-04-21
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-30
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-30
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2017-05-31
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Orthopedic Class 2 888.3660 2022-05-12
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3660 2022-05-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-30
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-30
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2018-02-07
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-30
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-30

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
1000517406 Paragon Medical Inc. Smithfield, UT, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K042598 Zimmer, Inc. PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES 2004-10-29
K190842 Jiangsu Trauhui Medical Instrument Co., Ltd. Comus Locking Plate systems 2020-02-03
K130510 Arthrex, Inc. ARTHREX COMPRESSION PLATES 2013-09-25
K202803 Newclip Technics Activmotion S DTO 2021-12-16
K904879 Endotec, Inc. BEUCHEL-PAPPAS GLENOID COMPONENT 1991-01-28

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0009-2007 Smith & Nephew Inc 1
Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007 Smith & Nephew Inc 1
Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06 Stryker Howmedica Osteonics Corp. 1
Allocraft TLIF Bone Inserter.
Z-0011-2007 Smith & Nephew Inc 1
Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1835831. Last updated year: 2026. Please use registration number 1835831 when referencing this establishment in official correspondence.
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