BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TELA BIO, INC.

    Reg #: 3010513348 · FEI: 3010513348 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    11
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    TELA BIO, INC.
    Registration Number
    3010513348
    FEI Number
    3010513348
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1 GREAT VALLEY PKWY STE 24
    City
    Malvern
    State
    PA
    ZIP
    19355
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241126

    Owner / Operator

    Firm Name
    TELA Bio
    Operator Number
    10048385
    Address
    1 Great Valley Parkway, Suite 24
    City
    Malvern
    State
    PA
    Postal Code
    19355
    Country
    US

    Products

    Device Name Product Code
    Mesh, Surgical FTM
    Mesh, Surgical, Polymeric FTL
    Guide, Surgical, Instrument FZX

    Proprietary Names

    OviTex PRS (STR) OviTex PRS Permanent OviTex Reinforced Tissue Matrix Shaped Cutting Template OviTex LPR Reinforced Tissue Matrix OviTex Reinforced Tissue Matrix with Permanent Polymer (OviTex) OviTex IHR Reinforced Tissue Matrix OviTex Reinforced Tissue Matrix OviTex PRS (LTR) OviTex Reinforced BioScaffold with Permanent Polymer (OviTex) OviTex PRS OviTex Reinforced Tissue Matrix with Resorbable Polymer (OviTex)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198