BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    SynthaGen HaTCP (OBS-1210-FO)

    Reg #: 3021015512 · FEI: 3021015512 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    51
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIOSTONE CO. LTD.
    Registration Number
    3021015512
    FEI Number
    3021015512
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Biocity Nottingham, Pennyfoot Street
    City
    Nottingham Nottinghamshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K202639

    Owner / Operator

    Firm Name
    Biostone Co. Ltd.
    Operator Number
    10083269
    Address
    Biocity Nottingham, Pennyfoot Street
    City
    Nottingham
    State
    Nottinghamshire
    Postal Code
    NG1 1GF
    Country
    GB
    Correspondent
    Wei-Jen Lo

    US Agent

    Business Name
    Dawa Medical LLC
    Contact Name
    Stephan Toupin
    Address
    7320 NW 12th street, 103
    City
    Miami
    State
    FL
    ZIP
    33126
    Country
    US
    Email
    [email protected]
    Phone
    786 7311159

    Products

    Device Name Product Code
    Filler, Bone Void, Calcium Compound MQV

    Proprietary Names

    SynthaGen HaTCP (OBS-1210-FO) BioViveSBG (1DE-OBS-01) OsteoXcell BA (OSBA-010) SynthaGen HaTCP (OBS-1205-FO) SynthaGen HaTCP (OBS-1202-FO) OsteoXcell BA (OSBA-005M) System 2 BA-MIS (SYS2-05M) Apex ASG (965-1203) BioViveSBG (1DE-OBS-03) si-Mochi OBS1201 si-Mochi OBS1205 si-Mochi OBS1210 OsteoXcell BA (OSBA-003) SynthaGen HaTCP (MIS-1205-FO) SynthaGen HaTCP (OBS-1203-FO) si-Mochi VET1203-O si-Mochi MIS1205 si-Mochi MIS1210 Apex ASG (965-1210) OsteoXcell BA (OSBA-001) si-Mochi VET1205-O OsteoXcell BA (OSBA-005) OsteoXcell BA (OSBA-002) BioViveSBG (1DE-OBS-05) BioViveSBG (1DE-OBS-10) Apex ASG (965-1201) System 2 BA (SYS2-10) System 2 BA (SYS2-03) System 2 BA (SYS2-01) Apex ASG (965-1205) BioViveSBG (1DE-MIS-10) BioViveSBG (1DE-OBS-02) si-Mochi VET1210-O Apex ASG (966-1205) Apex ASG (966-1210) SynthaGen HaTCP (MIS-1210-FO) si-MochiX (XOBS1203) si-Mochi VET1210-M si-MochiX (XOBS1205) si-Mochi VET1202-O si-Mochi OBS1202 si-Mochi VET1205-M SynthaGen HaTCP (OBS-1201-FO) System 2 BA (SYS2-02) si-Mochi VET1201-O OsteoXcell BA (OSBA-010M) Apex ASG (965-1202) System 2 BA (SYS2-05) si-Mochi OBS1203 BioViveSBG (1DE-MIS-05) System 2 BA-MIS (SYS2-10M)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)