prodisc® L Instruments

The prodisc® L Instruments are manual surgical instruments designed to enable placement, positioning, and removal of prodisc® L total disc replacement implants into the intervertebral disc space during spinal surgery.

Not stated in this summary. The document indicates the device was demonstrated to be substantially equivalent in design, materials, function, and manufacturing to predicate devices, but does not provide specific technical characteristic details.

Not stated in this summary. The document does not cite specific test methods or consensus standards such as ISO, IEC, or ASTM standards.

Centinel Spine argues substantial equivalence based on the prodisc® L Instruments sharing the same intended use (placement, positioning, and removal of disc implants), similar design and materials, and comparable function and manufacturing processes as the predicate prodisc® C instruments. The instruments were also evaluated in context of the reference prodisc® L Implants (PMA P050010), demonstrating consistency with an already-approved implant system.