BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    PURACON GMBH

    Reg #: 3004638532 · FEI: 3004638532 · Expires 2026
    View on FDA
    Products
    59
    Proprietary Names
    87
    Establishment Types
    1
    Classifications
    59

    Registration Details

    Registration Name
    PURACON GMBH
    Registration Number
    3004638532
    FEI Number
    3004638532
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Isarstrasse 1
    City
    Rosenheim Bavaria
    Country
    DE

    Owner / Operator

    Firm Name
    puracon GmbH
    Operator Number
    10028435
    Address
    Isarstrasse 1
    City
    Rosenheim
    State
    Bavaria
    Postal Code
    D-83026
    Country
    DE
    Correspondent
    Sofie Hoechstetter

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC
    Rod, Fixation, Intramedullary And Accessories HSB
    Bender HXW
    Clamp HXD
    Plate, Fixation, Bone HRS
    Prosthesis, Hip, Femoral Component, Cemented, Metal JDG
    Staple, Fixation, Bone JDR
    Alloy, Metal, Base EJH
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Pin, Fixation, Smooth HTY
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Appliance, Fixation, Spinal Interlaminal KWP
    Thoracolumbosacral Pedicle Screw System NKB
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Spinal Vertebral Body Replacement Device MQP
    Spinal Vertebral Body Replacement Device - Cervical PLR
    Nail, Fixation, Bone JDS
    Orthopedic Manual Surgical Instrument LXH
    Posterior Cervical Screw System NKG
    Surgical Instruments, G-U, Manual (And Accessories) KOA
    Rotator, Transverse IQP
    Stapler, Surgical GAG
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Cannula, Surgical, General & Plastic Surgery GEA
    Gauge, Depth HTJ
    Guide, Surgical, Instrument FZX
    Reamer HTO
    Catheter, Cholangiography GBZ
    Tray, Surgical, Instrument FSM
    Dispenser, Cement KIH
    Mixer, Cement, For Clinical Use JDZ
    Bone Cement LOD
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Screwdriver HXX
    Kit, Surgical Instrument, Disposable KDD
    Instrument, Bending Or Contouring HXP
    Bur, Dental EJL
    Implant, Endosseous, Root-Form DZE
    Abutment, Implant, Dental, Endosseous NHA
    Bit, Drill HTW
    Retractor GAD
    Bone Cement, Antibiotic MBB
    Accessories, Implant, Dental, Endosseous NDP
    Passer, Wire, Orthopedic HXI
    Instrument, Ent Manual Surgical LRC
    Tap, Bone HWX
    Template HWT
    Countersink HWW
    Bone Fixation Cerclage, Sublaminar OWI
    Drill, Dental, Intraoral DZA
    Rasp, Surgical, General & Plastic Surgery GAC
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Washer, Bolt Nut HTN

    Proprietary Names

    Clamps Flower Toe Cannulated and Solid Flex-ThreadTM Distal Fibula Intramedullary Nail System 88424, 8426, 8428, 8522, 8524, 8525, 8526, 8527, 8528, 8529, 853 BEE HA Cage cervical XX x YYmm ZZ POYA 3.5mm Medial Proximal Tibia System CASPIAN® Spinal System DENALI® MI Spinal System, DENALI® Spinal System, MESA® Small Stature Spinal System, MESA® Spinal MESA® Small Stature Spinal System Mohave Expandable Interbody System Cortical Screws TRIFT 3.5mm 1/3 Tubular Plates NGM WAVE Cage XX x Yymm ZZ CAPRI™ Corpectomy Cage System EVEREST® Spinal System CAPRI™ Corpectomy Cage System, EVEREST® Spinal System Orthopedic manual surgical instrument CASPIAN® Spinal System Calcaneus Plates MESA® Spinal System SALGINA 2.5mm Volar Distal Radius Plate, Standard, 5 Hole, Right SALGINA 2.5mm Dorsal Distal Radius Plate, 6 Hole, Right LEPORELLO 3.5mm Olecranon Plate 7 Hole, Left SALGINA 2.5mm Wrist Spanning Plate SALGINA 2.5mm Volar Distal Radius Plate, Distal Narrow, 3 Hole, Right SALGINA 2.5mm Volar Distal Radius Plate, Distal Narrow, 3 Hole, Left CASCELLA 3.5mm Superior Clavicle Plate, Lateral, 15 Hole, Left SALGINA 2.5mm Volar Distal Radius Plate, Distal Wide, 3 Hole, Left CASCELLA 3.5mm Superior Clavicle Plate, Lateral, 15 Hole, Right SALGINA 2.5mm Dorsal Distal Radius Plate, 6 Hole, Left SALGINA 2.5mm Volar Distal Radius Plate, Standard, 3 Hole, Left LEPORELLO 3.5mm Olecranon Plate 7 Hole, Right SALGINA 2.5mm Volar Distal Radius Plate, Distal Wide, 3 Hole, Right SALGINA 2.5mm Volar Distal Radius Plate, Standard, 3 Hole, Right SALGINA 2.5mm Volar Distal Radius Plate, Standard, 5 Hole, Left Apex Femoral Nail System LORRAINE 2.5/3.5mm Distal Humerus System BEE PLIF Cage XX x YYmm ZZ Cannulated screw Bone Screw Set, Ext. Mediant Anterior Cervical Plating System MIS Z-Pedicle Screw System SITTER 3.5mm Versatile System Depth Gauges Drill Guides BRUSIO Trauma Toolbox System TAMINA 3.5mm Proximal Humerus System neoWave C Cervical System Screw Racks Ti3D Cervical System neoWave LS Lumbar System Dental Bur IMPLANT, ENDOSSEOUS, ROOT-FORM Distal tibial A-Plate Straight Fibular Plate Anterior Lateral Distal Tibial Plate Medial Distal Tibial Plate Locking Fibular Plate ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS Apex Nailing System Sterile Guidewire LEPORELLO 3.5mm Olecranon Plates Cortical screws DALVAZZA 2.5mm Distal Ulna Plate TAMINA 3.5mm Proximal Humerus Plates SALGINA 2.5mm Volar Distal Radius Plates CASCELLA 3.5mm Superior Clavicle Plates POYA 3.5mm Lateral Proximal Tibia Plates Variable Angle Locking Screws YUKON OCT Spinal System Olecranon plate Lateral Humerus plate Midshaft and Distal Clavicle plates DENALI® Spinal System FJS945, FJS955 Trial Implants BEE Cage cervical XX x Yymm ZZ NILE™ Alternative Fixation System LORRAINE 3.5mm Distal Humerus System POYA 3.5mm Lateral Proximal Tibia System endosseous implant, root form Non-locking screw Variable angle non-locking screw Evans Plate- 3 hole, 4 hole SALTI 2.5/3.5mm Ankle System POYA 3.5mm Posteriomedial and Medial Proximal Tibia System Power Tool Attachment INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Bone screws OZARK Cervical Plate System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)