BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EAGLE MEDICAL PACKAGING STERILIZATION, INC.

    Reg #: 2028632 · FEI: 1000125025 · Expires 2026
    View on FDA
    Products
    39
    Proprietary Names
    63
    Establishment Types
    3
    Classifications
    39

    Registration Details

    Registration Name
    EAGLE MEDICAL PACKAGING STERILIZATION, INC.
    Registration Number
    2028632
    FEI Number
    1000125025
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2921 UNION RD
    City
    PASO ROBLES
    State
    CA
    ZIP
    93446
    Country
    US

    Regulatory Submissions

    510(k) Number
    K033639

    Owner / Operator

    Firm Name
    EAGLE MEDICAL, INC.
    Operator Number
    9005849
    Address
    2921 UNION RD, SUITE A, --
    City
    PASO ROBLES
    State
    CA
    Postal Code
    93446
    Country
    US
    Correspondent
    JODY - BIRKS

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
    Cerclage, Fixation JDQ
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Component, Traction, Invasive JEC
    Spinal Vertebral Body Replacement Device MQP
    Plate, Fixation, Bone HRS
    Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained LZJ
    Knife, Ophthalmic HNN
    Pin, Fixation, Smooth HTY
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Gauge, Depth HTJ
    Posterior Cervical Screw System NKG
    Appliance, Fixation, Spinal Interlaminal KWP
    Passer, Wire, Orthopedic HXI
    Rod, Fixation, Intramedullary And Accessories HSB
    Bulb, Inflation, For Endoscope FCY
    Prosthesis, Elbow, Hemi-, Radial, Polymer KWI
    Bit, Drill HTW
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Splint, Intranasal Septal LYA
    Orthopedic Manual Surgical Instrument LXH
    Wire, Surgical LRN
    Brush, Dermabrasion, Manual GED
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Lithotriptor, Electro-Hydraulic FFK
    Needle, Fistula FIE
    Implant, Malar LZK
    Prosthesis, Nose, Internal FZE
    Orthosis, Spinal Pedicle Fixation MNI
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Staple, Fixation, Bone JDR

    Proprietary Names

    Acumed Lower Extremity Congruent Plate System INnate Acumed Cannulated Cancellous Bone Screw Octane™ Straight Intervertebral Fusion Device, Ti Coated Octane Straight/IR PEEK Glenoid Resurfacing System Acutrak Plus Fixation System NanoPhix Cannulated Lag Screw System Acutrak Headless Compression Screw Acumed Bone Graft System TigerShark C Acumed Cerclage Crimp Sleeve AcuTie Sternal System Ascendant PEEK Harrier SA Stableloc External Fixator Octane T Acumed Congruent Bone Plate System ToeMotion TigerShark Lateral Threaded Acumed Scapula Congruent Bone Plate Acumed HubCap Wrist Fustin Plate Congruent Bone Plate System Extension Plates Talos L Talos P Talos A Talos T Ziplyft Blepharoplasty kit Acumed Tension Band Pin Unicompartmental Knee Resurfacing Prosthesis depth gauge Acumed Cortical Bone Screw Blackhawk Ti Guide wire Acumed Radius Rod Healthmark Industries Acumed Anatomic Radial Head System Drill Ascendant PC ArcPhix Acumed Small Bone External Fixator Spinal Jaxx Interbody Fusion Device Acumed Polarus Modular Shoulder System Acumed Bone Plate System Orthopedic Manual Surgical instrument Acumed Orthopaedic Osteo-Clage Wires Talos C Norsen Debrider Patello-Femoral Resurfacing System Summit Patella Plating System Acumed 3.5mm Extremity Screw Osteo-Clage Cerclage Cable System UreTron Multi Probe Lithotripter System SLIC Screw Repair System INFrame Acumed Polarus Cap Screw TriMed EOS Small Bone Fixation System - Staples & Pins Hanson Facial Implants SetX Pedicle Screw System TriMed Nitinol Staple System Osteo-Clage SS Bone Plate Acumed External Fixator Acumed Small Bone Locking Rod II

    Establishment Types

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