FDA clears 1st cervical cage for use in 4 contiguous levels — 5 details

Spinal Tech

San Diego-based NuVasive announced FDA clearance of its CoRoent Small Interbody System for up to four contiguous levels.  

Here are five things to know:

 

1. The CoRoent Small Interbody System has been cleared for intervertebral body fusion at multiple adjacent levels in the cervical spine, marking the first time a cervical cage has been cleared for use in up to four contiguous levels.

 

2.  Adults are commonly diagnosed with cervical radiculopathy and myelopathy secondary to cervical degenerative discs, leading to over 200,000 annual cervical surgical procedures in the U.S.

 

3. The CoRoent Small Interbody System is manufactured from PEEK-Optima, stabilizing the spinal motion segment as fusion occurs.

 

4. NuVasive president and COO Jason Hannon said, "This first and only clearance is an example of NuVasive's commitment to defining the components necessary to properly address an unmet clinical need and expand our presence and competitive positioning in the cervical market."

 

5. Implants included in the FDA clearance are CoRoent Small (S), CoRoent Small Lordotic (SL), CoRoent Small Lordotic Plus (SLP), CoRoent Small Hyperlordotic (SHL) and CoRoent Small Contoured (SC).

 

More articles on devices:
Dr. Steven Anagnost on implant innovation in the spine industry today

Burst Biologics begins spinal fusion study — 5 takeaways

Integra expands Cadence Total Ankle System — 5 notes

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