BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Slap Hammer

    Reg #: 3009051471 · FEI: 3009051471 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    92
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    CTL Medical Corporation
    Registration Number
    3009051471
    FEI Number
    3009051471
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2052 McKenzie Drive, Building 1
    City
    Carrollton
    State
    TX
    ZIP
    75006
    Country
    US

    Owner / Operator

    Firm Name
    CTL Amedica
    Operator Number
    10050984
    Address
    2052 McKenzie Drive, Building 1
    City
    Carrollton
    State
    TX
    Postal Code
    75006
    Country
    US
    Correspondent
    Kayla Chott

    Products

    Device Name Product Code
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    Slap Hammer Derotation Sleeve Reduction Driver Rod Pusher Counter Torque, Cross Connector Hex Socket Driver Paddle Disc Shaver Locking Plate Driver Shaft Driver, Torque Limiter K-Wire Holder Driver, Polyaxial Screw Torque Limiting Handle Kerrison Rongeur Rod Rocker Arm Cutter, Sleeve Driver, Reduction Screw T-Handle, Ratcheting ACIF Rasp Holder, Cross Connector Rescue Driver TLIF Cage Inserter, Bullet Tip Guide Pin Alignment Tool ACIF Cage Impactor Cutter, Pin Rod Bender Rod Persuader ACIF Trial Drill Bit Probe K-Wire Plate Holder Adjustable Stopper; Plate Bender; Hex Driver; Tap; Screw Remover; Temporary fixation pin; Temporary Fixation Pin driver Anti-Torque Device Rod Holding Forceps Compressor Driver, Set Screw, Star ACIF Cage Holder Distractor Adaptor, QC, 1/4" Square Female to Tri-Flat Male Small Ring Curette Rod Cutter Driver, Screw Derotation Sleeve Coupler Pituitary Tester Disc Elevator Rod Inserter Drill, Trilobe End TLIF Cage Graft Packing Block Screw Extractor Reduction Screwhead Cutter Drill, Cannulated Derotation Sleeve, Long In-Line Torquelimiting Set Screw Driver Rocker AO Coupling T-handle Modula T-handle Coronal Bender [Right/Left] Venus Basic Implant Leg - (standard, emergency, accessory) In-Line Torquelimiting Link Screw Driver Torque Wrench Venus Basic Instrument Cover Cutter Housing Introducer Rod Fork Retractor Rod Holder / Rod Holder Middle / Power Holder Derotator Hook Impactor Derotator Device Hook Holder 4 Hex, 5 Hex Drivers Alignment Guide Modular Instrument Holder Link Quick Driver Ball Tester - straight,curved Cannula Tap Spreader 4 Hex Screw Cannula Driver Venus Basic Implant Cover Removal Quick Driver Angled Hook Holder Set Screw Driver Guide DTS Guide 1/4" square ratchet handle Set Screw Driver Adaptor Venus Basic Instrument Container Screw Adjuster ACIF cage graft holder Plate-Cage Assembly Block Inserter Driver 3 Hex Venus Basic Implant Container

    Establishment Types

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