BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MEDSHAPE, INC.

    Reg #: 3007593722 · FEI: 3007593722 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    23
    Establishment Types
    2
    Classifications
    15

    Registration Details

    Registration Name
    MEDSHAPE, INC.
    Registration Number
    3007593722
    FEI Number
    3007593722
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1575 NORTHSIDE DR NW STE 440
    City
    Atlanta
    State
    GA
    ZIP
    30318
    Country
    US

    Regulatory Submissions

    510(k) Number
    K101934

    Owner / Operator

    Firm Name
    MedShape, Incorporated
    Operator Number
    10026693
    Address
    1575 Northside Drive NW STE 440
    City
    Atlanta
    State
    GA
    Postal Code
    30318
    Country
    US
    Correspondent
    Vladislava Zaitseva

    Products

    Device Name Product Code
    Rod, Fixation, Intramedullary And Accessories HSB
    Punch, Surgical LRY
    Orthopedic Manual Surgical Instrument LXH
    Staple, Fixation, Bone JDR
    Kit, Surgical Instrument, Disposable KDD
    Wrench HXC
    Bit, Drill HTW
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Nail, Fixation, Bone JDS
    Screw, Fixation, Bone HWC
    Guide, Surgical, Instrument FZX
    Tray, Surgical, Instrument FSM
    Washer, Bolt Nut HTN
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT

    Proprietary Names

    DynaNail Bone Punch Surgical Instruments and Accessories DynaNail TTC Tendon Shuttling Instrument Procedure Pack Transtibial Anterior Cruciate Ligament Kit Disposable Drill and Drill Guide Procedure Pack Tenodesis Accessory Instrument Procedure Pack EF1 External Fixation System Wrench Drills and Drill Guides Eclipse Soft Tissue Fastener DynaNail Hybrid DynaClip Delta Bone Staple DynaClip Quattro Bone Staple Evolve34 Correction Jig Evolve34 Joint Shim Evolve34 Joint Finder Evolve34 Instrument Sterilization Tray DynaFuse Fixation System EF1 External Fixation System DynaNail XL DynaNail Ankle Arthrodesis Intramedullary Nail Morphix Suture Anchor

    Establishment Types

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