BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SHARK SCREW DRILL 4.2

    Reg #: 3013820441 · FEI: 3013820441 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    59
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Precision Edge Surgical Products Co LLC
    Registration Number
    3013820441
    FEI Number
    3013820441
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1448 Lexamar Drive
    City
    Boyne City
    State
    MI
    ZIP
    49712
    Country
    US

    Owner / Operator

    Firm Name
    Precision Edge Surgical Products Company
    Operator Number
    10042577
    Address
    415 West 12th Avenue
    City
    Sault Sainte Marie
    State
    MI
    Postal Code
    49783
    Country
    US
    Correspondent
    Angela Gorsuch

    Products

    Device Name Product Code
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    SHARK SCREW DRILL 4.2 SHARK SCREW DRILL 3.25 SHARK SCREW DRILL 3.7 INNER CHANNEL REAMER Tibia Infrapatellar Insert Retainer Suprapatellar K-Wire Guide Obturator INNER CHANNEL REAMER SLEEVE Tibial Suprapatellar Insert Retainer Yellow 4.25mm Drill Sleeve Blue 6mm Drill Sleeve Tube Tissue Protector Mallet Guide 4.2MM CORTICAL DRILL Trocar 8mm x Length 220mm Fracture Reduction Tool Suprapatellar Anchoring Protection Sleeve Suprapatellar Trocar 4.25mm Drill Sleeve, Yellow (Length 138.5mm) Green Outer Drill Sleeve Trocar 8mm x Length 150mm Tibia Adapter Bolt Femoral Nail Extraction Bolt BLUE TROCAR, 227MM Insert Retainer Flexible driver with retention Hex Femur Connecting Bolt Green Outer Drill Sleeve (Length 129mm) Suprapatellar Standard Protection Sleeve Assembly Suprapatellar Protection Sleeve Handle Connector Orange 5.25mm Drill Sleeve Purple 5mm Drill Sleeve Tibial Infrapatellar Connecting Bolt Suprapatellar AO Mount Anchor Pin YELLOW TROCAR, 227MM Tibial Suprapatellar Connecting Bolt RETENTION HEX FLEXIBLE DRIVER ORANGE PURPLE TROCAR, 227MM ET HEX SCR DRIVER ASSY, SHORT RET HEX SCR DRIVER ASSY, LONG K-WIRE SLEEVE TAP FOR 9MM DUAL CORE SCREWS 6MM HXC 2 SLV F/ 2.5MM DRILL GUIDE STRAIGHT BALL TIP PROBE-SMALL 3.5MM THREADED REDUCTION TOOL SELF-TAPPING 78MM HEX IM NAIL REDUCTION TOOL 7.5MM SHAFT WITH CURVED TIP 3.2MM TROCAR FOR RECON LOCKING 1.6 SLV F/ 2MM DRILL GUIDE CONICAL EXTRACTION BOLT FOR TROCHANTERIC FIXATION NAILS PEDICLE MARKER-LONG BEADED IM REDUCTION TOOL/CURVED WITH QUICK COUPLING GRYPHON Flex Knotless Anchor Obturator PEDICLE MARKER-BEADED SMALL PEDICLE MARKER-LONG BEADED 2.7 SLV INS F/3.5MM DRILL GUIDE SMALL PEDICLE MARKER-BEADED TAP FOR 8MM DUAL CORE SCREWS 6MM HXC TAP FOR 7MM DUAL CORE SCREWS 6MM HXC SHART SCREW DRILL 2.85

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)