BEUDAMED
    37 results · 17ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System can be utilized anywhere monofilament wire has been previously found to be indicated.

    FDA Enforcement
    Class II ·Terminated·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·July 15, 2015

    EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·June 3, 2015

    DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·January 30, 2013

    DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·January 30, 2013

    DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant Component.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·January 30, 2013

    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·March 27, 2013

    DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·January 30, 2013

    DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Spinal Implant Component.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·January 30, 2013

    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·March 27, 2013

    PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·November 6, 2013

    PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·November 6, 2013

    PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·November 6, 2013

    DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·March 27, 2013

    Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·December 30, 2015

    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186852018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·November 30, 2016

    DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal Implant Component.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·January 30, 2013

    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·March 27, 2013

    DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·January 30, 2013

    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 18mm Item Code: 186864018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·November 30, 2016

    DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant Component.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·January 30, 2013