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    Akzenta International SA

    Manufacturer
    🇨🇭 Switzerland·2 Basic UDI-DIs·12 Devices·1 Importer

    AKZENTA|ONE

    Device
    EU MDR · Eu Md Class 1 ·Akzenta International SA·On the market·29 countries

    ORBIS

    Device
    EU MDR · Eu Md Class 1 ·Akzenta International SA·On the market·28 countries

    ORBIS

    Device
    EU MDR · Eu Md Class 1 ·Akzenta International SA·On the market·28 countries

    ORBIS

    Device
    EU MDR · Eu Md Class 1 ·Akzenta International SA·On the market·28 countries

    ORBIS

    Device
    EU MDR · Eu Md Class 1 ·Akzenta International SA·On the market·28 countries

    ORBIS

    Device
    EU MDR · Eu Md Class 1 ·Akzenta International SA·On the market·28 countries

    ORBIS

    Device
    EU MDR · Eu Md Class 1 ·Akzenta International SA·On the market·28 countries

    ORBIS

    Device
    EU MDR · Eu Md Class 1 ·Akzenta International SA·On the market·28 countries

    ORBIS

    Device
    EU MDR · Eu Md Class 1 ·Akzenta International SA·On the market·28 countries

    ORBIS

    Device
    EU MDR · Eu Md Class 1 ·Akzenta International SA·On the market·28 countries

    ORBIS

    Device
    EU MDR · Eu Md Class 1 ·Akzenta International SA·On the market·28 countries

    ORBIS

    Device
    EU MDR · Eu Md Class 1 ·Akzenta International SA·On the market·28 countries

    ULTRASAFE FACEMASKS

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Akzenta International SA·1 device

    ORBIS - PATIENT TOWELS

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Akzenta International SA·11 devices

    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.

    FDA Enforcement
    Class II ·Terminated·SPINEART SA·January 24, 2018

    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40 14-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.

    FDA Enforcement
    Class II ·Terminated·SPINEART SA·January 24, 2018

    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF TRY-PS-45 14-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.

    FDA Enforcement
    Class II ·Terminated·SPINEART SA·January 24, 2018

    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.

    FDA Enforcement
    Class II ·Terminated·SPINEART SA·January 24, 2018

    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.

    FDA Enforcement
    Class II ·Terminated·SPINEART SA·January 24, 2018