Camber Spine Gains FDA Clearance for SPIRA-P and SPIRA-T Implants
The FDA has granted Camber Spine 510(k) clearance for its 3-D printed SPIRA-P posterior lumbar spacer and SPIRA-T oblique posterior lumbar spacer devices.
The SPIRA-P spacer is designed to optimize load distribution and has a surface that promotes cell adhesion and bone growth.
The SPIRA-T spacer has the same basic features but is designed to accommodate “insert-and- rotate” transforaminal lumbar interbody fusion (TLIF) procedures and its shape is angled to optimize the inward curve of the lower back.
Camber Spine said it also plans to launch an articulating, arched TLIF SPIRA cage in early 2022.