BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SURGICAL THEATER, INC.

    Reg #: 3010197287 · FEI: 3010197287 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    SURGICAL THEATER, INC.
    Registration Number
    3010197287
    FEI Number
    3010197287
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    23645 Mercantile Road, Suite M
    City
    Beachwood
    State
    OH
    ZIP
    44122
    Country
    US

    Regulatory Submissions

    510(k) Number
    K170793

    Owner / Operator

    Firm Name
    Surgical Theater, Inc.
    Operator Number
    10044065
    Address
    23645 Mercantile Road, Suite M
    City
    Beachwood
    State
    OH
    Postal Code
    44122
    Country
    US

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Orthopedic Augmented Reality SBF

    Proprietary Names

    PlanXR SuRgical Planner (SRP) BrainStorm PE SNAP Endo SNAP Surgical Navigation Advanced Platform (SNAP) SyncAR SNAP VR MSNAP SyncAR Cranial SpineAR SNAP SyncAR Spine

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device