FDA Registration
Active
🇺🇸 United States
Paragon Medical Inc.
Reg #: 1835831
·
FEI: 3001814066
·
Expires 2026
Products
35
Proprietary Names
139
Establishment Types
1
Classifications
35
Registration Details
- Registration Name
- Paragon Medical Inc.
- Registration Number
- 1835831
- FEI Number
- 3001814066
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7350 E. 86TH ST.
- City
- Castleton
- State
- IN
- ZIP
- 46256
- 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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2013-01-31 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2007-12-28 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2017-12-15 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2017-12-15 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2017-12-15 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2018-02-07 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2022-05-11 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2022-05-11 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2022-05-11 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-01-30 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-01-30 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-01-30 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2013-01-30 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-01-30 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2013-01-20 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2025-01-07 |
| Template | HWT | Class 1 | Orthopedic | No | 2013-01-20 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2024-08-12 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2024-08-12 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2024-08-12 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2024-08-12 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2024-08-12 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2017-05-31 |
| Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | PKC | Class 2 | Orthopedic | No | 2022-05-12 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2018-02-07 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2013-01-31 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2013-01-31 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2013-01-31 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2013-01-31 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2013-01-31 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2013-01-31 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2013-01-30 |
| Mesh, Surgical, Metal | EZX | Class 2 | General, Plastic Surgery | No | 2013-01-30 |
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | KIJ | Class 1 | General, Plastic Surgery | No | 2022-05-11 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2008-10-14 |
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
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)