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510(k) Data Aggregation

    K Number
    K161371
    Device Name
    Sonoma Fifth Metatarsal Repair System
    Manufacturer
    SONOMA ORTHOPEDIC PRODUCTS, INC.
    Date Cleared
    2017-02-24

    (283 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    SONOMA ORTHOPEDIC PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sonoma Fifth Metatarsal Repair System is intended for use in the fixation of fractures of the fifth metatarsal, including Jones, avulsion and shaft fractures.
    Device Description
    The Sonoma Fifth Metatarsal Repair System is intended for use in the fixation of fractures and osteotomies of the fifth metatarsal, including Jones, avulsion, and shaft fractures. The Fifth Metatarsal Repair System includes the Sonoma Fifth Metatarsal Nail, End Caps and related instruments. Sonoma's Fifth Metatarsal Nail differs from traditional nails or rods as it utilizes Sonoma's ActivLoc® fixation gripper system at the distal end of the rod to supplement distal fixation without the use of screws, threads or K-wires. The implants are composed of 316 stainless steel per ASTM F138.
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    K Number
    K142945
    Device Name
    Sonoma Fibula Repair System
    Manufacturer
    SONOMA ORTHOPEDIC PRODUCTS, INC.
    Date Cleared
    2015-01-22

    (104 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    SONOMA ORTHOPEDIC PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sonoma Fibula Repair System is intended for use in the fixation of fibula fractures.
    Device Description
    The Sonoma Fibula Repair System includes all implants and instruments required for the fixation of fibula fractures. The Fibula Repair System includes the Sonoma Fibula Rod, Sonoma Bone Screws, End Cap and related instruments. Sonoma's Fibula Rod differs from traditional nails or rods as it utilizes Sonoma's ActivLoc® fixation gripper system at the proximal end of the rod to allow for proximal fixation without the use of screws. The implants are composed of 316 stainless steel per ASTM F138.
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    K Number
    K111550
    Device Name
    SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM)
    Manufacturer
    SONOMA ORTHOPEDIC PRODUCTS, INC.
    Date Cleared
    2011-08-19

    (77 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    SONOMA ORTHOPEDIC PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sonoma FasTrac Clavicle Fracture Repair Device is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.
    Device Description
    The Sonoma FasTrac Clavicle Fracture Repair Devices are stainless steel or titanium intramedullary fixation devices that utilize threads for fixation and a hub with cross screw. The device is available in nominal 3, 4, 5, and 6mm nominal OD and sizes 70-150mm nominal lengths. The Sonoma FasTrac Clavicle Fracture Repair Device is intended to be made of Ti-6Al-4V Titanium or 316L Stainless Steel.
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    K Number
    K100112
    Device Name
    SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)
    Manufacturer
    SONOMA ORTHOPEDIC PRODUCTS, INC.
    Date Cleared
    2010-09-28

    (257 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    SONOMA ORTHOPEDIC PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sonoma CWG Clavicle fracture repair device is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.
    Device Description
    Sonoma CWG devices are 316L SS intramedullary fixation devices that utilize internal grippers for fixation, similar to the Sonoma CMx predicate and also use a compression screw similar to the predicate Rockwood pin, to compress the fracture. The device is available in 4 & 5mm OD and sizes 90-120mm in length.
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    K Number
    K092110
    Device Name
    WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)
    Manufacturer
    SONOMA ORTHOPEDIC PRODUCTS, INC.
    Date Cleared
    2010-01-20

    (190 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    SONOMA ORTHOPEDIC PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K090304
    Device Name
    WAVEON WRX BONE FIXATION SYSTEM
    Manufacturer
    SONOMA ORTHOPEDIC PRODUCTS, INC.
    Date Cleared
    2009-08-28

    (203 days)

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

    SONOMA ORTHOPEDIC PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Waveon™ WRx (WristRocket™ Distal Radius System) is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable: - Joint destruction and/or subluxation visible on x-ray; - Osteotomy and repair of distal radius malunion with or without bone graft; - Non-displaced fractures. - Transverse fractures of the distal radius with or without comminution (e.g. AO classifications A2 and A3); - Transverse fractures of the distal radius with an extension into the joint with or without comminution (e.g. AO classification C2 and C1 respectively); - Failed fracture fixation with or without bone graft for the types of fractures above; - The above types of fractures (i.e. AO classifications non-displaced transverse, A2, A3, C1 and C2) in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.
    Device Description
    The WavEon™ WRx configuration consists of a flexible implant manufactured from stainless steel.
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    K Number
    K081832
    Device Name
    ENSPLINTCMX CLAVICLE PIN
    Manufacturer
    SONOMA ORTHOPEDIC PRODUCTS, INC.
    Date Cleared
    2008-10-10

    (105 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    SONOMA ORTHOPEDIC PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ENSPLINTCMx™ Clavicle Pin is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.
    Device Description
    The EnsplintCMxTM configuration consists of an implant made of 316 stainless steel.
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    K Number
    K080778
    Device Name
    ENSPLINT TM BONE SCREW
    Manufacturer
    SONOMA ORTHOPEDIC PRODUCTS, INC.
    Date Cleared
    2008-07-10

    (113 days)

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

    SONOMA ORTHOPEDIC PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ensplint™ Bone Screws are intended to treat fractures of various small and long bones. The Ensplint™ Bone Screws can also be used with the EnsplintRx Distal Radius System.
    Device Description
    HA Cortical Self-Tapping Bone Screws in diameters of 1.5mm to 5.0mm and lengths of 4mm to 90mm.
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    K Number
    K071809
    Device Name
    ENSPLINTRX BONE FIXATION SYSTEM
    Manufacturer
    SONOMA ORTHOPEDIC PRODUCTS, INC.
    Date Cleared
    2008-02-21

    (234 days)

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

    SONOMA ORTHOPEDIC PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ENSPLINTRx™ Distal Radius System is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable: - Joint destruction and/or subluxation visible on x-ray; . - Osteotomy and repair of distal radius malunion with or without bone graft; . - Non-displaced fractures in which the physician and patient opt for rigid stability . - Transverse fractures of the distal radius with or without comminution (e.g. AO . classifications A2 and A3) - Transverse fractures of the distal radius with an extension into the joint without . comminution (e.g. AO classification C1); - Failed fracture fixation with or without bone graft for the types of fractures above; . - The above types of fractures (i.e. AO classifications non-displaced transverse, A2, . A3, and C1) in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.
    Device Description
    The EnsplintRx™ configuration consists of a flexible implant manufactured from stainless steel.
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