BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OMNIlifeScience, Inc.

    Reg #: 1226188 · FEI: 3008342029 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    33
    Establishment Types
    2
    Classifications
    11

    Registration Details

    Registration Name
    OMNIlifeScience, Inc.
    Registration Number
    1226188
    FEI Number
    3008342029
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    480 Paramount Dr
    City
    Raynham
    State
    MA
    ZIP
    02767
    Country
    US

    Regulatory Submissions

    510(k) Number
    K053542

    Owner / Operator

    Firm Name
    Corin Group
    Operator Number
    9012268
    Address
    THE CORINIUM CENTRE, --
    City
    CIRENCESTER
    State
    Gloucestershire
    Postal Code
    GL7 1YJ
    Country
    GB
    Correspondent
    Aaron Brunt

    Products

    Device Name Product Code
    Neurological Stereotaxic Instrument HAW
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Orthopedic Stereotaxic Instrument OLO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    System, Image Processing, Radiological LLZ
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM APEX KNEE SYSTEM INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET APEX HCLA ACETABULAR CUP LINERS OMNI ARC MONOBLOCK HIP STEM OMNI ARC Anteverted Neck Hip Stem APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD TOTAL KNEE SURGETICS NAVIGATION SYSTEM UNI KNEE SURGETICS NAVIGATION SYSTEM APEX HIP SYSTEM BIPOLAR HEAD APEX ARC HIP STEM APEX-LNK POLY ACETABULAR CUP LINERS TOTAL HIP SURGETICS NAVIGATION SYSTEM OMNIBotics Knee System APEX K2 HIP SYSTEM APEX MODULAR ZIRCONIA FEMORAL HEAD TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM Apex Hip System INTERFACE ACETABULAR CUP LINERS TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES APEX MODULAR HA HIP STEM OMNI Anseris Hip Stem Apex K1 Hip Stem CADIMPLANT APEX MODULAR HEADS APEX MODULAR ACETABULAR CUP MONOBLOCK PRESS-FIT HIP STEM APEX MODULAR ALUMINA FEMORAL HEAD SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM APEX MODULAR HIP STEM APEX INTERFACE ACETABULAR SYSTEM CTLOGICS NAVIGATIONS SYSTEMS

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility