BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACL Workstation

    Reg #: 1828288 · FEI: 1828288 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    44
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ORCHID UNIQUE
    Registration Number
    1828288
    FEI Number
    1828288
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6688 Dixie Hwy
    City
    Bridgeport
    State
    MI
    ZIP
    48722
    Country
    US

    Owner / Operator

    Firm Name
    Unique Instruments Inc.
    Operator Number
    10042005
    Address
    6688 Dixie Hwy
    City
    Bridgeport
    State
    MI
    Postal Code
    48722
    Country
    US

    Products

    Device Name Product Code
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    ACL Workstation AVIATOR DRILL BIT Xcel Anchor System XIA CANN K-WIRE SHARP iTotal Steinman Pin Steinman Pin iTotal Reuseable Instruments iTotal Instruments AVS ANCHOR-L LUMBAR CAGE SYSTEM REFLEX HYBRID ITOTAL STEINMAN PIN 3MM P/N ED-02529 MHH Assembly Pad MHH Osteotomy Guide MANTIS NAVIGATION ITOTAL TIBIAL TACK PIN P/N ED-03162 LUXOR XIA III ITOTAL FEMORAL DRILL BIT 8MM W/HUDSON ADAPTOR P/N ED-03166 OASYS AVS ANCHOR-C CERVICAL CAGE SYSTEM OVERDRILL FOR 3.5MM STRYKER DESCRIPTION 703978 AVIATOR MHH Resection Guide RADIUS Slap Hammer PATELLA DRILL BIT, 5.5 MM W/HUDSON ADAPTER P/N ED-03167 OVERDRILL FOR 4.5MM STRYKER DESCRIPTION 703979 DRUJ Osteotomy Guide XIA PRECISION ITOTAL DRILL BIT 3MM DIAMETER P/N ED-03171 Depuy Synthes Orthopedic Manual Surgical Instrument 0310.499 OASYS 2k14 47563 – Fluted Surgical Drill Bit, Single Use, non-sterile RMR QC 3 FL 2.3mm & 2.7mm Cann Cannulated Drill 4.9mm Cannulated Countersink 8mm Cannulated Tap 6.5mm AR-9202-01H UNIVERS II Reamer with Hudson Connect 7601-N90010-K Navigated Short ø2.8 mm Drill Bit 7601-N90009-K Navigated Short ø2.3 mm Drill Bit AR-9202-02H USP II Reamer 6 Hudson Moss Miami Spine System Universal ACL Instrumentation Inter-Lock System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)