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510(k) Data Aggregation

    K Number
    K242814
    Device Name
    Tandry Q-Locking Plate System
    Manufacturer
    Microware Precision Co., Ltd.
    Date Cleared
    2024-11-14

    (57 days)

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

    Microware Precision Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tandry Q-Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies. The Tandry Q-Locking Plate System is indicated for the clavicle, pelvis, scapula and calcaneus, small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges, and long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia. Each plate is indicated for the following anatomic regions: - 1.5mm and 2.0mm Q-locking plates: Metacarpals, metatarsals, tarsals, and phalanges - 2.4mm Q-locking plates: Radius, wrist, and ulna - 3.5 mm Q-locking plates: Clavicle, scapula, humerus, olecranon, pelvis, fibula, calcaneus, and tibia - 5.0 mm Q-locking plates: Femur and tibia
    Device Description
    The Tandry Q-Locking Plate System consists of various sized plates, screws and instruments. The plates are designed to distribute for local anatomies and can accept, cortex, shaft and cancellous, locking (variable angle) screws. The screws are designed with self-tapping to promote the operation efficiency to insert the bones. Both plate and screw feature variable angle locking design.
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    K Number
    K230690
    Device Name
    Tandry Locking Plate System
    Manufacturer
    Microware Precision Co., Ltd.
    Date Cleared
    2023-08-17

    (157 days)

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

    Microware Precision Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tandry Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies. The Tandry Locking Plate System is indicated for the clavicle, pelvis, scapula and calcaneus, small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges, and long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia. In addition, the Tandry Locking Hip Plate System is indicated for fixation of fractures to the proximal femur. The plates are indicated for use in trochanteric, intertrochanteric, and basilar neck fracture. Each plate is indicated for the following anatomic regions: - 1.5mm and 2.0mm locking plates Metacarpals, metatarsals, tarsals, and phalanges - 2.4mm locking plates Radius, wrist, and ulna - 3.5 mm locking plates Clavicle, scapula, humerus, olecranon, pelvis, fibula, calcaneal, and tibia - 5.0 mm locking plates Femur and tibia
    Device Description
    The Tandry Locking Plate System consists of various sized plates, screws and instruments. The plates are designed to distribute for local anatomies and can accept locking, cortex, shaft and cancellous screws. The screws are designed with self-tapping to promote the operation efficiency to insert the bones. The instruments are used for completing the surgery.
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    K Number
    K220360
    Device Name
    Tandry CMF Plate System
    Manufacturer
    Microware Precision Co., Ltd.
    Date Cleared
    2022-11-10

    (275 days)

    Product Code
    JEY, DZL
    Regulation Number
    872.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    Microware Precision Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tandry CMF System is a Maxillofacial plate and screw system intended for osteotomy, stabilization and rigid fixation of maxillofacial/midface fractures and reconstruction including infraorbital area and maxillofacial, and mandibular and maxillary correction surgery. Each plate is indicated to be used in the following anatomic regions: - · 1.2mm upper-face plates Orbital floor region, zygomatic region, and dento-alveolar region - · 1.5mm mid-face plates Zygomatic region, orbital floor region, and maxilla - · 2.0 mm mini plates Orthognathics midface/mandible - · 2.0/2.3mm mandible plates Mandibular
    Device Description
    The Tandry CMF Plate System consists of various sized plates and screws. The plates and screws are fabricated from pure titanium and Ti-6Al-4V. The plates are designed to distribute for respective anatomical and indicated areas, besides, they can be used with self-tapping, self-drilling, emergency self-tapping and locking screws.
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    K Number
    K220359
    Device Name
    Tandry Compression Screw System
    Manufacturer
    Microware Precision Co., Ltd.
    Date Cleared
    2022-09-20

    (224 days)

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

    Microware Precision Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tandry Compression Screw System is intended for the treatment of fractures, and fusions of bone with the appropriate screw size.
    Device Description
    Tandry Compression Screw System consists of 2.8mm, 4.1mm, 4.7mm, 5.5, and 7.5mm cannulated compression screw, 2.0mm compressions screw and 2.0mm compression pin. The 2.0mm compression pin features a beak-off groove between a shaft and compression screw body, the shaft can be separated from the compression screw body by bending it back and forth. The screw system has multiple lengths depending on the diameter of the screws and pins are fabricated from Ti-6Al-4V and anodized.
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    K Number
    K182929
    Device Name
    BIO-RAY A-1 Anchor Screw System
    Manufacturer
    Microware Precision Co., Ltd.
    Date Cleared
    2019-11-06

    (380 days)

    Product Code
    OAT
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Microware Precision Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BIO-RAY A-1 Anchor Screw System is intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It's used temporarily and intended after orthodontic treatment has been completed. The screw is intended for single use only.
    Device Description
    The BIO-RAY A-1 Anchor Screw System is made of stainless steel 316L (ASTM F138) and titanium alloy Ti-6Al-4V (ASTM F136). Electrolytic polishing is for surface treatment of stainless steel screws and anodizing is for surface treatment of Ti-6Al-4V screws. There is a self-drilling and self-tapping feature in the screw tip for insertion and removal . The screw head designs include a mushroom, hook, or none head feature for attachment to orthodontic appliances. The screws are available in various configurations, shapes and sizes.
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    K Number
    K171904
    Device Name
    Tandry Locking Plate System
    Manufacturer
    Microware Precision Co., Ltd.
    Date Cleared
    2018-09-18

    (449 days)

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

    Microware Precision Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tandry Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies for bones including the clavicle, pelvis, scapula and calcaneal, small bones including the metatarsals, tarsals and phalanges; long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia. In addition, Tandry Locking Hip Plate System is in fixation of fractures to the proximal femur. The plates are indicated for use in trochanteric, pertrochanteric, and basilar neck fracture. Each plate is indicated to be used in the following anatomic regions: - 1.5mm and 2.0mm locking plates Metacarpals, metatarsals, tarsals, and phalanges - 2.4mm locking plates Radius, wrist, and ulna - 3.5 mm locking plates Clavicle, scapula, humerus, olecranon, pelvis, fibula, calcaneal, and tibia - 5.0 mm locking plates Femur and tibia
    Device Description
    The Tandry Locking Plate System consists of various sized plates, screws and instruments. The plates are designed to distribute for local anatomies and can accept locking, cortex, shaft and cancellous screws. The screws are designed with self-tapping to promote the operation efficiency to insert the bones. The instruments are used for completing the surgery.
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    K Number
    K111008
    Device Name
    MICROWARE BONE PLATES AND BONE SCREW
    Manufacturer
    MICROWARE PRECISION CO., LTD.
    Date Cleared
    2012-05-02

    (387 days)

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

    MICROWARE PRECISION CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Microware Bone Plates and Bone Screws are provided non-sterile. Microware Bone Plates and Bone Screws are intended to treat fractures of various bones, including the clavicle, pelvis, scapula, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals and phalanges). Microware Bone Plates and Bone Screws Accessories: 1. The round washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone. 2. The spherical washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone. In addition, it can be applicable on the insertion at acute angles. 3. The spiked washer is used for ligament reattachment or fixation. 4. The support screw is anchored in cancellous bone by its thread. It supports the countersink head of a cannulated screw in cancellous bone.
    Device Description
    The added devices do not change the original intended use, material, label, and package. The added devices with changes are described as follows: 1. Added cortex, cancellous, and shaft screws are designed with self-tapping flutes and are easier to insert into the bone than non-self-tapping screws. 2. Added cortex screws 1.5 and 2.0mm are designed with a cruciform recess and can be applied with a cruciform tool. 3. Added screws of all sizes are designed with a hexalobular socket and they can improve torque transmission to facilitate easy insertion and removal. 4. Added cannulaed screws extend diameter specification with 6.5, 4.5, 4.0, 3.0 and 2.4mm. 5. Added implants include the round washer, spherical washer, spiked washer, and support screw which can be used with or without other implants. 6. Added screws extend length specifications.
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    K Number
    K072562
    Device Name
    MICROWARE BONE PLATES AND BONE SCREWS
    Manufacturer
    MICROWARE PRECISION CO., LTD.
    Date Cleared
    2008-12-04

    (450 days)

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

    MICROWARE PRECISION CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Microware Bone Plates and Bone Screws are provided non-sterile. Microware Bone Plates and Bone Screws are intended to treat fractures of various bones, including the clavicle, pelvis, scapula, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals and phalanges). Microware DHS/DCS Plate System is provided non-sterile. Microware DHS/DCS Plate System is intended for use in fixation of fractures to the proximal femur. The system is indicated for use in trochanteric, pertrochanteric, intertrochanteric, and basilar neck fracture.
    Device Description
    The Bone Plates and Bone Screws system & DHS/DCS Plate System consist of non-sterile bone plate and bone screw implants. The plates are devices, which are fastened to bone for purpose of providing fixation. They are principally differentiated by their function. Thus there are five kinds of styles: dynamic compression plate (DCP), tubular, special, mini and dynamic hip screw/dynamic condylar screw (DHS/DCS). The shape of the plate is an adaptation of the plate to the local anatomy and doesn't denote any function. Thus the name depends on the biomechanical function the plate is performing. Every plate is divided various types as following: Plate Name | Geometry Shane ---|--- 3 | lengthening-narrow, broad, lengthening-broad, straight Special | L-shaped, T-shaped, spoon, cobra, lateral tibia head, condylar buttress, head, and hook Mini | Straight, L-shaped, T-shaped, condylar, special, and reconstruction DHS/DCS | Dynamic Hip Screw, Dynamic Condylar Screw The series in size of Microware bone screws and bone plates except DHS/DCS are divided into mini, small and large. The range of plates in thickness are from 1.0 to 6.0 mm, width from 3.8 to 17 mm, length from 17 to 359 mm, and hole number from 2 to 22 holes. On the other hand, the screws used either to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone. The screws are differentiated by the manner in which they are inserted into bone, their function, their size, and the type of bone they are intended for. Thus there are four kinds of style: cortex, cancellous, malleolar, and cannulated. All screws have a hexagonal recess; this feature has proven itself to be of great advantage at the time of the screw removal and insertion. The range of screws in thread is diameter from 1.5 to 7.3 mm, total length from 6 to 150 mm. The DHS/DCS Plate System consists of DHS/DCS plate, DHS/DCS Screw, DHS/DCS Compression Screw, and 4.5mm Cortex Screw (self-tapping). The DHS Plates are available with short and standard barrel which length is 25mm and 38mm respectively. And the barrel angles are available in 95', 135 , 140', 145', and 150'. The self-tapping 4.5mm Cortex Serew can be used to fix the DHS/DCS Plate to the femoral shaft. The DHS/DCS Screw is available in total length from 50 to 145mm, thread length 22mm, shaft diameter 7.9mm, and outer diameter 12.5 to 14mm. The thread of DHS/DCS screw has a buttress type. The DHS/DCS Compression Screw can be used to achieve fracture compression. Its dimension is available with thread length 26mm and outer diameter 4.0mm.
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