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    FDA Registration Active 🇺🇸 United States

    APOLLO Ankle Fracture Plates, 1/3 Tubular Plate, 7 Holes - F3-0004-007

    Reg #: 3014967149 · FEI: 3014967149 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    126
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    GLW, Inc.
    Registration Number
    3014967149
    FEI Number
    3014967149
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    930 Sylvan Ave Ste 125
    City
    Englewood Cliffs
    State
    NJ
    ZIP
    07632
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213005

    Owner / Operator

    Firm Name
    GLW, INC.
    Operator Number
    10058309
    Address
    930 Sylvan Ave, Suite 125
    City
    Englewood Cliffs
    State
    NJ
    Postal Code
    07632
    Country
    US
    Correspondent
    Arundhati Radhakrishnan

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC

    Proprietary Names

    APOLLO Ankle Fracture Plates, 1/3 Tubular Plate, 7 Holes - F3-0004-007 APOLLO Ankle Fracture Plates / 2.9mm / Non-Locking Screw / 2.9 x 26mm - F3-0029-026 APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7 x 16mm - F3-0037-016 APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7 x 47.5mm - F3-0037-047 APOLLO Ankle Fracture Plates, 1/3 Tubular Plate, 6 Holes - F3-0004-006 APOLLO Ankle Fracture Plates, Fibular Plate, Right, 6 Holes - F3-2001-006 APOLLO Ankle Fracture Plates / 2.9mm / Non-Locking Screw / 2.9 x 08mm - F3-0029-008 APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7 x 10mm - F3-1037-010 APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3 x 32.5mm - F3-0043-032 APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 20mm - F3-1029-020 APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7 x 60mm - F3-1037-060 APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7 x 57.5mm - F3-0037-057 APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3 x 67.5mm - F3-0043-067 APOLLO Ankle Fracture Plates, Medial Mal. Plate, 4 Holes - F3-0003-004 APOLLO Ankle Fracture Plates / 2.9mm / Non-Locking Screw / 2.9 x 10mm - F3-0029-010 APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7 x 30mm - F3-1037-030 APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7 x 26mm - F3-0037-026 APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7 x 38mm - F3-1037-038 APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3 x 25mm - F3-0043-025 APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 08mm - F3-1029-008 APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7 x 50mm - F3-1037-050 APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7 x 22mm - F3-0037-022 APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7 x 12mm - F3-0037-012 APOLLO Ankle Fracture Plates, Hook Plate, 6 Holes - F3-0006-006 APOLLO Ankle Fracture Plates, Fibular Plate, Left, 4 Holes - F3-1001-004 APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7 x 47.5mm - F3-1037-047 APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7 x 18mm - F3-0037-018 APOLLO Ankle Fracture Plates, 1/3 Tubular Plate, 5 Holes - F3-0004-005 APOLLO Ankle Fracture Plates / 2.9mm / Non-Locking Screw / 2.9 x 28mm - F3-0029-028 APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 22mm - F3-1029-022 APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7 x 14mm - F3-0037-014 APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7 x 60mm - F3-0037-060 APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7 x 10mm - F3-0037-010 APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 28mm - F3-1029-028 APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7 x 55mm - F3-0037-055 APOLLO Ankle Fracture Plates, Posterior Plate, Left, 4 Holes - F3-1002-004 APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7 x 20mm - F3-1037-020 APOLLO Ankle Fracture Plates / 2.9mm / Non-Locking Screw / 2.9 x 37.5mm - F3-0029-037 APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7 x 45mm - F3-1037-045 APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7 x 42.5mm - F3-0037-042 APOLLO Ankle Fracture Plates / 2.9mm / Non-Locking Screw / 2.9 x 24mm - F3-0029-024 APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7 x 36mm - F3-0037-036 APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7 x 16mm - F3-1037-016 APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7 x 28mm - F3-0037-028 APOLLO Ankle Fracture Plates, Posterior Plate, Right, 3 Holes - F3-2002-003 APOLLO Ankle Fracture Plates, Hook Plate, 5 Holes - F3-0006-005 APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 16mm - F3-1029-016 APOLLO Ankle Fracture Plates / 2.9mm / Non-Locking Screw / 2.9 x 16mm - F3-0029-016 APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7 x 36mm - F3-1037-036 APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7 x 40mm - F3-0037-040 APOLLO Ankle Fracture Plates, Fibular Plate, Right, 4 Holes - F3-2001-004 APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 18mm - F3-1029-018 APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7 x 34mm - F3-0037-034 APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3 x 35mm - F3-0043-035 APOLLO Ankle Fracture Plates, Syndesmotic Plate, 2 Holes - F3-0005-002 APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7 x 14mm - F3-1037-014 APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7 x 55mm - F3-1037-055 APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3 x 60mm - F3-0043-060 APOLLO Ankle Fracture Plates / 2.9mm / Non-Locking Screw / 2.9 x 40mm - F3-0029-040 APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7 x 32mm - F3-0037-032 APOLLO Ankle Fracture Plates, 1/3 Tubular Plate, 10 Holes - F3-0004-010 APOLLO Ankle Fracture Plates / 2.9mm / Non-Locking Screw / 2.9 x 12mm - F3-0029-012 APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7 x 52.5mm - F3-0037-052 APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3 x 62.5mm - F3-0043-062 APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3 x 37.5mm - F3-0043-037 APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 14mm - F3-1029-014 APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7 x 57.5mm - F3-1037-057 APOLLO Ankle Fracture Plates, 1/3 Tubular Plate, 8 Holes - F3-0004-008 APOLLO Ankle Fracture Plates, Posterior Plate, Left, 3 Holes - F3-1002-003 APOLLO Ankle Fracture Plates / 2.9mm / Non-Locking Screw / 2.9 x 20mm - F3-0029-020 APOLLO Ankle Fracture Plates / 2.9mm / Non-Locking Screw / 2.9 x 32.5mm - F3-0029-032 APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3 x 52.5mm - F3-0043-052 APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3 x 42.5mm - F3-0043-042 APOLLO Ankle Fracture Plates, Hook Plate, 4 Holes - F3-0006-004 APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 30mm - F3-1029-030 APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 32.5mm - F3-1029-032 APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3 x 30mm - F3-0043-030 APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3 x 27.5mm - F3-0043-027 APOLLO Ankle Fracture Plates, Hook Plate, 3 Holes - F3-0006-003 APOLLO Ankle Fracture Plates, Fibular Plate, Left, 8 Holes - F3-1001-008 APOLLO Ankle Fracture Plates, Medial Mal. Plate, 3 Holes - F3-0003-003 APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 37.5mm - F3-1029-037 APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7 x 28mm - F3-1037-028 APOLLO Ankle Fracture Plates, Washer, 7.5mm OD - F3-0075-000 APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7 x 52.5mm - F3-1037-052 APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7 x 24mm - F3-1037-024 APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3 x 50mm - F3-0043-050 APOLLO Ankle Fracture Plates / 2.9mm / Non-Locking Screw / 2.9 x 22mm - F3-0029-022 APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7 x 26mm - F3-1037-026 APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7 x 34mm - F3-1037-034 APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7 x 32mm - F3-1037-032 APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7 x 42.5mm - F3-1037-042 APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3 x 45mm - F3-0043-045 APOLLO Ankle Fracture Plates, Medial Mal. Plate, 5 Holes - F3-0003-005 APOLLO Ankle Fracture Plates, Posterior Plate, Right, 4 Holes - F3-2002-004 APOLLO Ankle Fracture Plates, 1/3 Tubular Plate, 12 Holes - F3-0004-012 APOLLO Ankle Fracture Plates, Fibular Plate, Right, 8 Holes - F3-2001-008 APOLLO Ankle Fracture Plates / 2.9mm / Non-Locking Screw / 2.9 x 35mm - F3-0029-035 APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7 x 45mm - F3-0037-045 APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3 x 70mm - F3-0043-070 APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 40mm - F3-1029-040 APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7 x 30mm - F3-0037-030 APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3 x 65mm - F3-0043-065 APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3 x 47.5mm - F3-0043-047 APOLLO Ankle Fracture Plates, 1/3 Tubular Plate, 4 Holes - F3-0004-004 APOLLO Ankle Fracture Plates, Fibular Plate, Left, 6 Holes - F3-1001-006 APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 12mm - F3-1029-012 APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7 x 38mm - F3-0037-038 APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7 x 18mm - F3-1037-018 APOLLO Ankle Fracture Plates / 2.9mm / Non-Locking Screw / 2.9 x 30mm - F3-0029-030 APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 26mm - F3-1029-026 APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7 x 50mm - F3-0037-050 APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 10mm - F3-1029-010 APOLLO Ankle Fracture Plates / 2.9mm / Non-Locking Screw / 2.9 x 14mm - F3-0029-014 APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7 x 12mm - F3-1037-012 APOLLO Ankle Fracture Plates, Syndesmotic Plate, 4 Holes - F3-0005-004 APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7 x 40mm - F3-1037-040 APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3 x 40mm - F3-0043-040 APOLLO Ankle Fracture Plates / 2.9mm / Non-Locking Screw / 2.9 x 18mm - F3-0029-018 APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 24mm - F3-1029-024 APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7 x 20mm - F3-0037-020 APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3 x 55mm - F3-0043-055 APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3 x 57.5mm - F3-0043-057 APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 35mm - F3-1029-035 APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7 x 24mm - F3-0037-024 APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7 x 22mm - F3-1037-022

    Establishment Types

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