510(k) K210595

SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers by Camber Spine Technologies, LLC — Product Code MAX

K210595 is an FDA 510(k) premarket notification submitted by Camber Spine Technologies, LLC for the device "SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers". The FDA issued a decision of Substantially Equivalent on June 15, 2021. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Camber Spine Technologies, LLC has at least 10 other 510(k) clearances on record.