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510(k) Data Aggregation

    K Number
    K212334
    Device Name
    GEO Extremity and Ankle Plating System
    Manufacturer
    Gramercy Extremity Orthopedics, LLC
    Date Cleared
    2021-09-21

    (56 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    Gramercy Extremity Orthopedics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K210534
    Device Name
    GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
    Manufacturer
    Gramercy Extremity Orthopedics, LLC
    Date Cleared
    2021-03-26

    (30 days)

    Product Code
    HRS, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    Gramercy Extremity Orthopedics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System is in the stabilization and fixation of the first metatarsal-phalangeal joint in the foot for surgical fusion (arthrodesis), osteotomy, nonumion or revision surgery.
    Device Description
    The GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System consists of anatomically contoured, lowprofile plates in a variety of configurations of length, left and right versions, and degrees of dorsiflexion and abduction. The plates accept both fixed angle locking screws and non-locking Extremity Plating System (EPS) screws. Fixed angle cortical locking screws are available in diameters of 2.7mm and 3.5. Non-locking cortical screws are available in 2.7mm, 3.5mm and 4.0mm; and non-locking cancellous screws in 4.0mm. Screws lengths are offered in 10-40mm for the 2.7mm diameter plate screws and in 10 – 60mm in 3.5mm and 4.0mm diameter plate screws. All components (implants and the associated instruments) are provided sterile and for single use only.
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    K Number
    K202817
    Device Name
    GEO Bone Screw System
    Manufacturer
    Gramercy Extremity Orthopedics, LLC
    Date Cleared
    2020-10-22

    (28 days)

    Product Code
    HWC, HTN
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Gramercy Extremity Orthopedics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GEO Bone Screw System is indicated for bone fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachment. Surgical indications include fixation of malunion and nonunion, acute fractures, repetitive stress fractures, malleolar, talus, and greater tuberosity fractures, Jones fracture and 5th metatarsal fracture fixation and bone reconstruction where appropriate for the size of the device.
    Device Description
    The GEO Bone Screw System consists of sterile, stand-alone headed and headless, cannulated and solid, threaded bone screws, washers, and instrumentation. Bone screws are available in a variety of diameters and lengths including partially and fully threaded designs to accommodate application in varying bone sizes (for the Jones Fracture / 5th metatarsal procedures only the 4.0mm-6.5mm diameter screws are appropriate). Optional washers are available and sized to correspond with bone screws. K-wires and general, manual orthopedic instrumentation is provided and intended to facilitate implantation. Instrumentation includes wire quide handles. AO drive handles, drill bits, taps, depth gauges, countersinks, tissue protectors, hexalobe driver tips and screw diameter templates. GEO implants are comprised of titanium alloy. All implants are provided for single use only and sterilized by exposure to gamma irradiation.
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    K Number
    K200108
    Device Name
    GEO 1st MTP Joint Arthrodesis Plating System
    Manufacturer
    Gramercy Extremity Orthopedics, LLC
    Date Cleared
    2020-03-26

    (69 days)

    Product Code
    HRS, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    Gramercy Extremity Orthopedics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GEO 1st MTP Joint Arthrodesis Plating System is indicated for use in the stabilization and fixation of the first metatarsal-phalangeal joint in the foot for surgical fusion (arthrodesis), osteotomy, nonunion or revision surgery.
    Device Description
    The GEO 188 MTP Joint Arthrodesis Plating System consists of anatomically contoured, low- profile plates in a variety of configurations of length, left and right versions, and degrees of dorsiflexion and abduction. The plates accept both fixed angle locking screws and non-locking screws. Fixed angle cortical locking screws are available in diameters of 2.7mm and 3.5. Non-locking cortical screws are available in 2.7mm, 3.5mm and 4.0mm; and non-locking cancellous screws in 4.0mm. All screws are offered in lengths of 10-40mm. The system also includes associated instrumentation consisting of plate tacks, quide-wire, drill bit, drill bit, drill guides (locking and non-locking), AO driver tip, reamers, depth gauge, non-locking drill guide handle, AO driver handle, and templates for plate and reamer sizing. All GEO 1ª MTP Joint Arthrodesis Plating System components (implants and instruments) are provided sterile and for single use only.
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    K Number
    K182212
    Device Name
    Geo Staple System
    Manufacturer
    Gramercy Extremity Orthopedics, LLC
    Date Cleared
    2019-01-11

    (149 days)

    Product Code
    JDR
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    Gramercy Extremity Orthopedics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GEO Staple System is intended for fixation of small bone fragments, fixation of osteotomies, and joint arthrodesis.
    Device Description
    The GEO Stable System consists of symmetric, barbed and smooth, superelastic Nitinol allov compression bone staples in varying lengths and widths. The System also includes associated instrumentation consisting of a stable inserter, drill bit and locator pins. The nitinol implant material conforms to ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants. GEO Staples are offered in widths ranging from 8mm – 25mm. To facilitate implantation, GEO Staples are provided preloaded in the Staple Inserter. All GEO Staple System components (implants and instruments) are provided sterile and for single use only.
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