BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Allosource1516 (SDB) - XEMPLIFI Plus Putty

    Reg #: 2030598 · FEI: 1000518731 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Synergy Health AST, LLC
    Registration Number
    2030598
    FEI Number
    1000518731
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9020 Activity Rd Ste D
    City
    SAN DIEGO
    State
    CA
    ZIP
    92126
    Country
    US

    Regulatory Submissions

    510(k) Number
    K103036

    Owner / Operator

    Firm Name
    Synergy Health AST, LLC
    Operator Number
    10028672
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP
    Filler, Bone Void, Calcium Compound MQV

    Proprietary Names

    Allosource1516 (SDB) - XEMPLIFI Plus Putty Allosource1516 (SDB) - NuVasive Propel DBM Putty Plus Allosource1516 (SDB) - BIO DBM Plus Putty w Cancellous Allosource1516 (SDB) - NuVasive Propel DBM Gel Plus Allosource1516 (SDB) - Stryker DBM Plus Putty (with cancellous) Allosource1516 (SDB) - Puros DBM RPM Putty with Chips Allosource1516 (SDB) - AlloFuse Plus Paste Allosource1516 (SDB) - BIO DBM Plus Paste w Cancellous Allosource1516 (SDB) - XEMPLIFI Plus Paste Allosource1516 (SDB) - AlloFuse Plus Putty Allosource1516 (SDB) - Stryker DBM Plus Paste (with cancellous) Allosource1516 (SDB) - StimuBlast Putty Allosource1516 (SDB) - HERO DBM Plus Paste Allosource1516 (SDB) - HERO DBM Plus Putty Allosource1516 (SDB) - StimuBlast CB Paste Allosource (SDB) - Puros DBM RPM Paste, Cancellous Allosource1516 (SDB) - BiomaX Bone Graft Putty Plus Chips

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)