BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PARCUS MEDICAL , L.L.C.

    Reg #: 3007319107 · FEI: 3007319107 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    42
    Establishment Types
    2
    Classifications
    19

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    Registration Details

    Registration Name
    PARCUS MEDICAL , L.L.C.
    Registration Number
    3007319107
    FEI Number
    3007319107
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6423 Parkland Dr
    City
    Sarasota
    State
    FL
    ZIP
    34243
    Country
    US

    Regulatory Submissions

    510(k) Number
    K183501

    Owner / Operator

    Firm Name
    Medacta International SA
    Operator Number
    10024526
    Address
    Strada Regina
    City
    Castel San Pietro
    State
    Ticino
    Postal Code
    6874
    Country
    CH
    Correspondent
    Stefano Baj

    Products

    Device Name Product Code
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Washer, Bolt Nut HTN
    Screw, Fixation, Bone HWC
    Accessories, Arthroscopic NBH
    Awl HWJ
    Bit, Drill HTW
    Guide, Surgical, Instrument FZX
    Screwdriver HXX
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Starter, Bone Screw HWD
    Component, Traction, Non-Invasive KQZ
    Tap, Bone HWX
    Passer HWQ
    Extractor HWB
    Stripper, Surgical HRT
    Orthopedic Manual Surgical Instrument LXH
    Instrument, Manual, Surgical, General Use MDM
    Elevator HTE

    Proprietary Names

    Twist AP Suture Anchors TWIST PEEK SUTURE ANCHOR Synd-EZ SS Synd-EZ Ti V-LOX TITANIUM SUTURE ANCHOR PEEK CF PUSH-IN SUTURE ANCHORS Arthroscopic Instruments GFS SLiK Fix Screw Awl PPEK CF INTERFERENCE SCREW V-LOX PEEK CF SUTURE ANCHOR Drill Bit AcTiFlip , GFS Ultimate Hip Surgical Instrument Fastener, Fixation, Nondegradable, Soft Tissue Screwdriver GRAFT FIXATION SYSTEM Bone screw starter GFS Ultimate Titanium Interference Screw Titanium Interference Screws SLiK Anchors GFS BTB Traction Instrument Bone Tap V-lox Titanium Suture Anchors and Miti Suture Anchors X-Twist Biocomposite Suture Anchor PEEK CF PUSH-IN SUTURE ANCHOR DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR Knotless AP Suture Anchors MITI TITANIUM SUTURE ANCHOR Passer X-Twist PEEK Suture Anchor Knotless PEEK and PEEK CF Push-In Suture Anchor Extractor ATLAS Stripper Manual Orthopedic Instruments ORTHOPEDIC DISPOSABLE SURGICAL NEEDLE Surgical Instrument - Elevator ActiFlip

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility