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    CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

    FDA Enforcement
    Class II ·Ongoing·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·March 17, 2021

    CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 85mm Material Number: 66-585 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

    FDA Enforcement
    Class II ·Ongoing·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·March 17, 2021

    CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 38mm Material Number: 66-238 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

    FDA Enforcement
    Class II ·Ongoing·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·March 17, 2021

    CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 24m Material Number: 66-124 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

    FDA Enforcement
    Class II ·Ongoing·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·March 17, 2021

    CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 80mm Material Number: 66-480 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

    FDA Enforcement
    Class II ·Ongoing·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·March 17, 2021

    CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 22mm Material Number: 66-122 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

    FDA Enforcement
    Class II ·Ongoing·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·March 17, 2021

    CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material Number: 66-5105 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

    FDA Enforcement
    Class II ·Ongoing·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·March 17, 2021

    CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 26mm Material Number: 66-226 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

    FDA Enforcement
    Class II ·Ongoing·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·March 17, 2021

    CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 28mm Material Number: 66-228 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

    FDA Enforcement
    Class II ·Ongoing·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·March 17, 2021

    CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 18mm Material Number: 66-118 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

    FDA Enforcement
    Class II ·Ongoing·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·March 17, 2021

    CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 72mm Material Number: 66-472 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

    FDA Enforcement
    Class II ·Ongoing·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·March 17, 2021

    CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 88mm Material Number: 66-488 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

    FDA Enforcement
    Class II ·Ongoing·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·March 17, 2021

    CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 63mm Material Number: 66-363 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

    FDA Enforcement
    Class II ·Ongoing·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·March 17, 2021

    Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of these components. 1. Patient Physiological Monitor, 2. Laptop Computer, 3. Stand w/wheels, 4. Patient cables, 5. Software components (Respiratory and Cardiac Spectral Frequency Signal Processor). The different monitor components that can be used in the system are one of the following per system are as follows: Patient Physiological Monitors used: CJPS Vital Pro, Zoe Medical Nightingale Monitoring system, Ivy Biomedical model 405P, Software components: Ansar ANS C 3000. The device is also referred to as the ANS-C3000.

    FDA Enforcement
    Class II ·Terminated·Ansar Group, Inc. Dba Ansar Medical Technologies, Inc·August 27, 2014

    CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 84mm Material Number: 66-484 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

    FDA Enforcement
    Class II ·Ongoing·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·March 17, 2021

    CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 34mm Material Number: 66-234 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

    FDA Enforcement
    Class II ·Ongoing·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·March 17, 2021

    CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 60mm Material Number: 66-460 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

    FDA Enforcement
    Class II ·Ongoing·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·March 17, 2021

    CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 80mm Material Number: 66-580 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

    FDA Enforcement
    Class II ·Ongoing·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·March 17, 2021

    CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 90mm Material Number: 66-590 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

    FDA Enforcement
    Class II ·Ongoing·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·March 17, 2021

    CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 45mm Material Number: 66-345 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

    FDA Enforcement
    Class II ·Ongoing·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·March 17, 2021