(113 days)
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No
The summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for "temporary stabilization of the anterior spine from C2 to T1 during the development of a cervical spinal fusions", which serves a therapeutic purpose for various spinal conditions.
No
The device is an implantable plate system for spinal fusion and stabilization, not a tool for diagnosing medical conditions. It is used to treat existing conditions rather than to identify them.
No
The device description explicitly states that the system consists of physical components: anterior cervical bone plates, screws, and screw locking tabs, all manufactured from titanium alloy. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The NEO Anterior Cervical Plate System is a physical implantable device (plates, screws, and locking tabs) made of titanium alloy. It is surgically implanted into the spine.
- Intended Use: The intended use is for temporary stabilization of the anterior spine during spinal fusion. This is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
The information provided clearly describes a surgical implant, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The NEO Anterior Cervical Plate System is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with:
- Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies);
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- Spondylolisthesis
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- Trauma (including fractures or dislocations);
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- Spinal cord stenosis:
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- Deformity or curvatures (i.e. kyphosis, lordosis or scollosis);
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- Tumors:
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- Pseudarthrosis;
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- Failed previous fusions.
WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
- Failed previous fusions.
Product codes
KWQ
Device Description
The NEO Anterior Cervical Plate System consists of various sizes of anterior cervical bone plates. screws and screw locking tabs. Components are available in a variety of sizes to fit patient anatomy. All components are manufactured from implant grade titanium alloy 6A1-4V ELI per ASTM F-136. The NEO ACPS components will be supplied clean and "NON-STERILE".
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
C2 to T1
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The results of the static and fatigue strength testing for the NEO Anterior Cervical Plate System demonstrate comparable mechanical properties to the predicate devices listed.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
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Life Spine, LLC NEOTM Cervical Plating System 510(k) Summary of Safety and Effectiveness
KO