BEUDAMED
    FDA Registration Active 🇨🇳 China

    Paragon Medical Device (Changzhou) Co., Ltd.

    Reg #: 3007539489 · FEI: 3007539489 · Expires 2026
    View on FDA
    Products
    52
    Proprietary Names
    263
    Establishment Types
    2
    Classifications
    52

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    Registration Details

    Registration Name
    Paragon Medical Device (Changzhou) Co., Ltd.
    Registration Number
    3007539489
    FEI Number
    3007539489
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3A GDH Industrial Park, No. 16 Chuangye Road
    City
    Changzhou Jiangsu
    Country
    CN

    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

    US Agent

    Business Name
    Paragon Medical
    Contact Name
    Stephane Langlois
    Address
    8 Matchett Dr
    City
    Pierceton
    State
    IN
    ZIP
    46562
    Country
    US
    Email
    [email protected]
    Phone
    435 5355456

    Products

    Device Name Product Code
    Orthopedic Manual Surgical Instrument LXH
    Clamp HXD
    Instrument, Cutting, Orthopedic HTZ
    Orthopedic Stereotaxic Instrument OLO
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Driver, Prosthesis HWR
    Tap, Bone HWX
    Bit, Drill HTW
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Neurological Stereotaxic Instrument HAW
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Template HWT
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Mallet HXL
    Wrench HXC
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Guide, Surgical, Instrument FZX
    Rod, Fixation, Intramedullary And Accessories HSB
    Retractor GAD
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Screwdriver HXX
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer MBV
    Pin, Fixation, Smooth HTY
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing NJL
    Tamp HXG
    Plate, Fixation, Bone HRS
    Instrument, Manual, Surgical, General Use MDM
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    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
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Pusher, Socket HXO
    Broach HTQ
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
    Punch, Surgical LRY
    Tray, Surgical, Instrument FSM
    Plate, Bone, Growth Control, Pediatric, Epiphysiodesis OBT
    Thoracolumbosacral Pedicle Screw System NKB
    Appliance, Fixation, Spinal Interlaminal KWP
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Impactor HWA
    Tray, Surgical LRP
    Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
    Software For Diagnosis/Treatment OSN
    Punch, Femoral Neck HWP

    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 Tornier HRS Max Driver Intermediate Tap, Locking, AO Fluted Pin Various Drills for Foot Surgery (Twist Drill, Over-Drill, Drill Bit) Universal Pin Persona® The Personalized Knee System PERSONA NATURAL TIBIA BASEPLATES KEEL TIB PUNCH GUIDE SZ1.5-4 Persona Revision Knee System Mallet Navlock Black and Blue Trackers AMBI CHIMAERA INSTRUMENT TRAY, EMPTY CHIMAERA INSTRUMENT TRAY EXTRA EMPTY EXTRACTION INSTRUMENT TRAY EMPTY INITIA INTERMEDIATE SIZE BROACH CASE LEGION Screwdriver Zimmer Persona Personalized Knee System PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER Persona® The Personalized Knee System STERILIZATION BOX EMPTY PERI-LOC Drill Bit, AO RG 9.5 BALLAST TAP LONG RG BALLAST TAP LONG RG 10.5 BALLAST TAP LONG RG 11.5 BALLAST TAP LONG RG BALLAST DRILL 4.2 x 70 LONG RG AWL-TIP TAP LONG RG SOLERA AWL-TIP TAP SHORT RG DRILL 3 x 30 SHORT RG DRILL 3 x 30 LONG RG 8.5 BALLAST TAP LONG Driver 9735253 T-Handle 5mm Hex ANKLE HINDFOOT NAILING SYSTEM - INSERTION INSTRUMENTS CASE EMPTY ANKLE HINDFOOT NAILING SYSTEM - DRILLS AND REAMERS CASE EMPTY ANKLE HINDFOOT NAILING SYSTEM - EXTRACTION INSTRUMENTS CASE EMPTY NavLock Trackers and Robotic Reference Frame TRUELOK TRAUMA - INSTRUMENTS CASE, US TRUELOK TRAUMA CASE, US GALAXY WRIST TRAY EMPTY Triathlon Primary & MIS Patella Preparation Caddy Triathlon MIS Femoral Preparation Tray TS Femoral Augments Trials Tray TRIATHLON REVISION INSTRUMENTS FEMORAL CONE PREP 1 TRAY Journey II Restoration Modular Conical Distal Reamers Tray (10mm-17mm) TS TCG Insert Trials (Size 1-5, 22-31mm) Tray RESTORATION MODULAR CONICAL DISTAL STEM TRIALS TRAY 115MM HINGE FEMORAL TRIALS - LEFT TRAY Restoration Modular Conical Distal Reamers Tray (18mm-23mm) Triathlon Pro Miscellaneous Instruments Tray HINGE TCG TRAY Revision Finishing Tray TS Misc. Instruments Tray TRIATHLON REVISION INSTRUMENTS TIBIAL CONE UPPER TRAY TRIDENT TRITANIUM INSERT TRIALS TRAY Hinge Insert Trials Tray TS Insert Trials (9-19mm) Tray Revision Tibial Prep Tray Revision IM Reamers (20-25mm) Tray FEMORAL AUGMENT TRIALS AND DISTAL SPACERS CADDY Triathlon 5511 PS Femoral Trials Tray - Left TS Femoral Trials - Left Tray Trident II Reamers (38-66mm) Tray TS Femoral Trials - Right Tray TRIATHLON PRO PS BOX REAM PREPARATION TRAY Triathlon Pro PS Insert Trials Tray (Size 0-7) Femoral Distal Spacers Caddy REVISION BASEPLATE FINISHING TRAY Triathlon Primary & MIS Patella Preparation Tray TS Universal Baseplate Finishing Tray TRIATHLON PRO MISCELLANEOUS INSTRUMENTS TRAY WITH CR PATELLA TRACK TRIALS Femoral Distal Augment Trials (Size 1-4) Caddy Offset Reamer Handle Tray Trident Tritanium Window Trials Tray Accolade II Broach Tray Accolade II Basic Tray Trident II Core Reamers (38-66mm) Tray Acetabular Reamers (67-80)mm Tray Trident Window Trials Tray Tritanium Window Trials Tray Trident II Auxiliary Trials Tray Acetabular Reamers (36-66)mm Tray Trident Constrained Insert Trials Tray Trident II General Instruments Tray Exeter Retractor Tray Trident II Core Trials Tray Modular Dual Mobility Tray MIS TKA IM LID General Femoral Tray LCCK ART SURFACE PROV CASE LCCK STEM PROV BASE, FLUTED ELEOS™ INSTRUMENTATION TRAY, TRAY LID STANDARD ELEOS™ INSTRUMENTATION TRAY, MALE-MALE MIDSECTION TRIALS, TRAY 12 LCCK STEM PROV CASE, STR/OFS Exeter Broach Tray ELEOS™ INSTRUMENTATION TRAY, RESURFACING STEM TRIALS, TRAY 5 ELEOS™ INSTRUMENTATION TRAY, PATELLA INSTRUMENTS, TRAY 10 Exeter Extension Broach Tray ELEOS™ INSTRUMENTATION TRAY, FEMORAL RESURFACING INSTRUMENTS, TRAY 9 Exeter Plug Trial Tray Triathlon Tritanium Central Femoral Cone Preparation Tray ELEOS™ INSTRUMENTATION TRAY, GENERAL RESURFACING INSTRUMENTS, TRAY 8 ELEOS™ INSTRUMENTATION TRAY, TIBIAL RESURFACING TRIALS, TRAY 6 LCCK BLOCK AUGMENT PROV BASE WalterLorenz Surgical Assist Arm ELEOS™ INSTRUMENTATION TRAY, AUGMENT PREPARATION AND TRIALING INSTRUMENTS, TRAY 13 ELEOS™ INSTRUMENTATION TRAY, PROXIMAL TIBIA TRIALS, TRAY 11 LCCK FEM AUG & BOX PROV TRAY Tray, Surgical, Instrument LCCK FEM CUTTING INST CASE ELEOS™ INSTRUMENTATION TRAY, PIN CADDY, KIT TO TRAY 8 GENERIC STACKABLE LID ASSY LCCK REAMER BASE W/ T-HANDLE ELEOS™ INSTRUMENTATION TRAY, SEGMENTAL STEM TRIALS, TRAY 3 NEXGEN FEM RESECT BASE ASSY ELEOS™ INSTRUMENTATION TRAY, PROXIMAL DISTAL FEMORAL SEGMENTAL TRIALS, TRAY 4 ELEOS™ INSTRUMENTATION TRAY, REAMERS, TRAY 1 ELEOS™ INSTRUMENTATION TRAY, TIBIAL RESURFACING PREPARATION INSTRUMENTS, TRAY 7 ELEOS™ INSTRUMENTATION TRAY, ASSEMBLY/DISASSEMBLY INSTRUMENTS, TRAY 2 ELEOS™ INSTRUMENTATION TRAY, TRAY LID SMALL STERILIZATION TRAY TIB TM CONE A.L.P.S. Clavicle Plating System VPC Instruments STERILIZATION BASE TIB TM CONE VIPER PRIME CFXFEN XTAB TRAY 2 Persona Modular Case Component Persona Modular Case Componet PRIMARY DELIVERY SYS VIPER PRIME SCREW CADDY VIPER PRIME CFXFEN X-TAB TRAY SR LID BASE ASSEMBLY BASE Restoration Modular Conical Distal Reamers Tray (24mm-28mm) Triathlon Pro 4IN1's & Spacer Blocks Tray Triathlon Pro Patella Preparation Caddy HINGE FEMORAL PREP TRAY SR LID BASE ASSEMBLY LID PRIME TOP IMPLANT TRAY Triathlon Pro Femoral Trials Tray - Right Triathlon Pro CS Insert Trials Tray (Size 0-7) TS TCG Insert Trials (Size 6-8, 22-31mm) Tray TRIATHLON INSERT TRIAL TRAY-CS(SIZE 1-8) TRIATHLON INSERT TRIAL TRAY-CR(SIZE 1-8) TS Insert Trials (size 1-5, 22-31mm) Tray TRIATHLON REVISION INSTRUMENTS FEMORAL CONE PREP 2 TRAY Universal Lid Triathlon Primary/Express/MIS Tibial Preparation Tray Revision General Tray HINGE FEMORAL TRIALS - RIGHT TRAY Femoral Posterior Augment Trials (Size 1-8) Caddy Revision IM Reamers (8-19mm) Tray Femoral Distal Augment Trials (Size 5-8) Caddy Triathlon PS Box Cutting Guides Tray TS Femoral Prep Tray Triathlon Pro Femoral Trials Tray - Left Triathlon Pro CR Insert Trials Tray (Size 0-7) Revision 100mm Stem Trials (9-25mm) Tray Revision 150mm Stem Trials (9-25mm) Tray Offset Adapter Trials Caddy ETS Instrument Tray Triathlon Pro Miscellaneous Instruments Caddy RESTORATION MODULAR GENERAL INSTRUMENTS TRAY TS Insert Trials (size 6-8, 22-31mm) Tray TRIATHLON REVISION INSTRUMENTS TIBIAL CONE LOWER TRAY Z1 Hip System Restoration Modular Proximal Cone Reamers Tray (19mm-31mm) Triathlon Pro Tibial Preparation Tray Restoration Modular Auxiliary Instruments Tray TS TCG Tray Restoration Modular Conical Distal Stem Trials Tray 155mm Triathlon Pro Patella Preparation Tray Triathlon Primary & Express Femoral Preparation Tray Restoration Modular Extraction Instruments Tray TS TCG Insert Trials (9-19mm) Tray TRIATHLON INSERT TRIAL TRAY-PS(SIZE 1-8) Triathlon 5511 PS Femoral Trials Tray - Right EXTENDED PLUS LINE CADDY EMPTY QUAD PLATE PLUS CADDY EMPTY EIGHT PLATE PLUS CADDY EMPTY CORTICAL TAP, DUAL LEAD, NAVIGATED-?5.5MM TAP RBT071545 RG CORTICAL 4.5 AWL-TIP SHORT TAP, CORTICAL DUAL LEAD-?6.5MM TAP RBT071565 RG CORTICAL 6.5 AWL-TIP SHORT CORTICAL TAP, DUAL LEAD, NAVIGATED-?7.5MM TAP RBT071655 RG CORTICAL 5.5 AWL-TIP LONG TAP RBT071555 RG CORTICAL 5.5 AWL-TIP SHORT TAP RBT071675 RG CORTICAL 7.5 AWL-TIP LONG CORTICAL TAP, DUAL LEAD, NAVIGATED-?6.5MM CORTICAL TAP, DUAL LEAD, NAVIGATED-?4.5MM TAP RBT071665 RG CORTICAL 6.5 AWL-TIP LONG TAP, CORTICAL DUAL LEAD-?4.5MM TAP RBT071575 RG CORTICAL 7.5 AWL-TIP SHORT TAP, CORTICAL DUAL LEAD-?5.5MM TAP, CORTICAL DUAL LEAD-?7.5MM TAP RBT071645 RG CORTICAL 4.5 AWL-TIP LONG TRAUMA TRAY, TL-HEX, EMPTY NavLock Trackers AGILE NAIL STERILIZATION BOX EMPTY AGILE NAIL STERILIZATION BOX EXTRACTION EMPTY CRANIAL REDUCING TUBE

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Sterilize Medical Device for Another Party (Contract Sterilizer)