BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Centerpiece Plate Fixation System

    Reg #: 1000517406 · FEI: 1000517406 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    58
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Paragon Medical Inc.
    Registration Number
    1000517406
    FEI Number
    1000517406
    Status
    Active
    Expiry Year
    2025
    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
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    Centerpiece Plate Fixation System C-STEM AMT STD NECK SEGMENT- SZ2/3 C-STEM AMT SZ 3A NK SEGMENT LITe Funnel Freehand Drill IMN Instruments ø4.2x130mm Bone Tap Drilling Guide ø2/2.7 Drill Guide Supracondylar Locking Drill IMN Instruments ø3.5x360mm Screw Insertion Sleeve ø9mm Drill Guide ø6.55 Guide Wire D3xL300 "Insertion Sleeve for ø3.2mm Guide Wires" Freehand Drill IMN Instruments ø3.5x130mm Locking Drill IMN Instruments ø4.2x360mm Threaded Guide Wire D3.2xL300 (Sterile) Zimmer Biomet Direct Measuring Gauge Guide Wire D3.2xL300 Trocar SPS-MonoAxial Locking Set 5mm Inserter sleeve Freehand Drill IMN Instruments ø4.2x185mm Freehand Drill IMN Instruments ø3.5x185mm Parallel Drill Guide Insert ø3.2 compression Insert ø3.2 neutral Guide Wire D3.2xL300 (Sterile) Depth Gauge 0-110mm For Screws ø2.7/3.5/4 Depth Gauge 0-120mm Depth Gauge 0-150mm for Screws: ø4.5/6.5mm Drilling Guide ø2.5/3.5 Drill Sleeve Handle Depth Gauge 0-70mm for Screws: ø2.7/3.5/4mm Trocar SPS-MonoAxial Locking Set 4mm Drill Sleeve D4.3 Drill Sleeve D3.1 Insert ø2.5 neutral Lag Screw Tap Sleeve Insert ø2.5 compression Tissue prot. sleeve ø6.5/4.5 Depth Gauge 0-150mm for Screws: ø2.7/3.5/4mm Lag Screw Depth Gauge Threaded Guide Wire D3.2xL300 Insert ø2.5 support Drill Gauge (Percutaneous) Drilling Guide ø3.2/4.5 Guide Wire Distractor Twist Drill C-STEM AMT STD NECK SEGMENT- SZ6/7 C-STEM AMT HO NECK SEGMENT- SZ 0/1 Guide Wire with Ruler Tube C-STEM AMT HO NECK SEGMENT- SZ4/5 C-STEM AMT HO NECK SEGMENT- SZ2/3 Orthopedic Manual Surgical Instrument C-STEM AMT SZ 2A NK SEGMENT C-STEM AMT STD NECK SEGMENT- SZ0/1 INSERTION SHIM - HANDLE IMN™ Instruments

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)