BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LifeNet Health

    Reg #: 3015724777 · FEI: 3015724777 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    16
    Establishment Types
    3
    Classifications
    10

    Registration Details

    Registration Name
    LifeNet Health
    Registration Number
    3015724777
    FEI Number
    3015724777
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    845 Airtech Parkway, Suite 198
    City
    Plainfield
    State
    IN
    ZIP
    46168
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242799

    Owner / Operator

    Firm Name
    LIFENET HEALTH
    Operator Number
    9079121
    Address
    1864 CONCERT DR., --
    City
    VIRGINIA BEACH
    State
    VA
    Postal Code
    23453
    Country
    US
    Correspondent
    MICHAEL A PLEW

    Products

    Device Name Product Code
    Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon OWY
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Filler, Bone Void, Non-Osteoinduction MBS
    Filler, Bone Void, Calcium Compound MQV
    Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP
    Motor, Surgical Instrument, Ac-Powered GEY
    Screw, Fixation, Bone HWC
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Syringe, Piston FMF

    Proprietary Names

    SpeedFlex ReadiGraft BLX DBM & CC PUTTY ReadiGraft BLX DBM Putty PliaFX Flo FlexiGRAFT GraftLink FlexiGRAFT Sutured Lateral Ankle Tendon Construct FlexiGRAFT GraftLink TS FlexiGRAFT Connect EXT FlexiGRAFT Connect FlexiGRAFT QuadLink FlexiGRAFT DualLink I/C Graft Chamber Optium DBM Vesuvius DBM Putty Allograft MIS Delivery System ViviGen MIS Delivery System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Device in the United States for Export Only Manufacture Medical Device