API
< Back to all clusters
[BUSINESS] · South Korea, United States · 2 sources

started · updated

L&K Biomed receives additional FDA approval for BluEX-C cervical cage

L&K Biomed, a specialist in spinal implants, has received additional U.S. Food and Drug Administration (FDA) approval for its cervical expandable cage, ‘BluEX-C’. The new approval expands the footprint sizes of the device, allowing for a wider range of contact areas between the cage and the spinal bone.

This expansion was driven by feedback from U.S. medical professionals who requested more diverse sizing to better accommodate varying patient anatomical structures during surgery. The BluEX-C is designed to adjust in height from 4mm at insertion to a maximum of 15mm after expansion.

L&K Biomed has already completed registration with 14 hospitals and clients in the United States, where the product is being utilized at premium pricing. The company plans to expand its clinical references and supply volume to accelerate growth in the global cervical market.

Entities

L&K Biomed · U.S. Food and Drug Administration