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510(k) Data Aggregation

    K Number
    K143200
    Device Name
    MIS Z-Pedicle Screw System
    Manufacturer
    Z-Medical GmbH & Co. KG
    Date Cleared
    2015-02-03

    (89 days)

    Product Code
    NKB, MNH, MNI
    Regulation Number
    888.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Z-Medical GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MIS Z-Pedicle Screw System is intended to provide immobilization and stabilization of the spinal segments for posterior, non-cervical pedicle fixation in skeletally mature patients as an adjunct to fusion for the following indications: · degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies): · spondy lolisthesis (grades 3 and 4) at L5-S1 - · trauma (i.e., fracture or dislocation) - · spinal stenosis - · curvatures (i.e.,scoliosis, kyphosis, and/or lordosis) - · tumor - · pseudoarthrosis - · failed previous fusion.
    Device Description
    The MIS Z - Pedicle Screw System consists of a variety of Pedicle screws and rods in different sizes. The devices are intended to provide immobilization of the spinal segments for posterior, noncervical pedicle fixation in skeletally mature patients as an adjunct to fusion. The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g. osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye. Z-Pedicle Screws: Material: ASTM F136 (Ti-6Al-4V ELI) Length: 35mm to 55 mm Diameter: 5, 6, 7, 8 mm Z- Rods: Material: ASTM F136 (Ti-6Al-4V ELI) Length: 35mm to 300mm Diameter: 5,5 mm
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    K Number
    K121277
    Device Name
    Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE
    Manufacturer
    Z-MEDICAL GMBH & CO. KG
    Date Cleared
    2012-11-07

    (194 days)

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

    **Z-MEDICAL GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Z-Medical SnapOff screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include: - Fixation of small bone fragments - Weil osteotomy - Mono-cortical fixation - Osteotomies and fractures fixation in the foot and hand The Z-Medical double thread compression screws are indicated for fixation of bone fractures or bone reconstruction. Examples included: - Fixation of bone fragments or small bone fractures - Fracture management in the foot and hand - Arthrodesis in hand, foot or ankle surgery - Mono or Bi-cortical osteotomies in the foot and hand The Z-Medical's guide wires are intended to perform as fixation and stabilization unit of bone fractures or as guidance at insertion of implants into the skeletal system. The Z-Medical Staples are indicated for fixation of bone fractures, bone reconstruction, ligament, soft tissue and tendon. Examples included: - Fixation of bone fragments or small bones fractures - Fracture management in the foot and hand
    Device Description
    Z-Snap Off Screw: Main application is forefoot surgery. Intended to connect bones or bone fragments. Material: ASTM F136 (Ti-6AI-4V ELI), Length: 11 mm to 14 mm, Diameter: 2 mm. Z-Double Thread Compression Screw: Mainly used in forefoot surgery. Most common use is in the "Scart"-osteotomy. Cannulated to work with a guide wire and drilled in manually. Material: ASTM F136 (Ti-6Al-4V ELI), Length: 10 mm to 36 mm, Diameter: 3 and 4 mm. Z-Guide Wire: Used in all fields of surgery. Main applications are: determine the correct position for e.g. screws or drills, or fixation of bones, fragments. Usually put in by machine. Also used to drill holes, e.g. to apply staples. Material: ASTM F 138 (1.4441), Length: 80 mm to 380 mm, Diameter: 0.7 mm to 6.35 mm, End Styles: Trocar, Type: Smooth. Z-Staple: Implants for fixing bones or fragments. Use the SnapOff-technology. The distal end can be used as drilling gauge as well as grip to put in the staple. After reaching the final position, the grip can be snapped off by moving sideways. Material: ASTM F136 (Ti-6Al-4V ELI), Size: 8 mm to 25 mm, Method of insertion: Staple inserter and SnapOff technique.
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