Spine medtech earning FDA nods in 2024

Spinal Tech

Several spine implants and medtech products earned FDA approvals and breakthrough designations in the first half of 2024.

Vuze Medical's software-based 3D spine guidance earned FDA 510(k) clearance for its second iteration.

Canary Medical earned the FDA's breakthrough designation for its smart lumbar spine cartridge.

Spinal Simplicity earned FDA 510(k) clearance for its Wolff's Law anterior cervical plate system.

Providence Medical Technology's Corus navigation access system was cleared by the FDA for use with Medtronic's StealthStation system for posterior spinal fusions.

Eminent Spine's SI screw system earned the FDA's 510(k) clearance.

Spineart received FDA 510(k) clearance for its SCARLET AC-Ti secured anterior cervical cage.

Orthopedic technology company Implanet earned FDA clearance for its hybrid fixation system, the Jazz Spinal System. 

ZygoFix earned FDA clearance for its zLock device.

Spinal Simpicity's Patriot-SI posterior implant system for sacroiliac joint fusion earned FDA 510(k) clearance.

Medtronic earned FDA approval for its Inceptiv closed-loop spinal cord stimulator.

SAIL Fusion earned FDA clearance for its BowTie sacroiliac joint fusion system.

Xstim earned FDA premarket application approval for its spine fusion stimulator.

Bioretec earned the FDA's breakthrough device designation for its RemeOs spinal interbody cage.

Woven Orthopedics earned its second FDA 510(k) clearance for the Ogmed implantable sleeve.

Nevro earned FDA 510(k) clearance to use its sacroiliac joint fixation system without having to include a lateral screw.

Momentum Health earned FDA 510(k) clearance for Momentum Spine, an artificial intelligence-powered app for spine care.

SI-Bone earned FDA 510(k) clearance of the iFuse Bedrock Granite implant system in a smaller diameter.

ClearPoint Neuro earned FDA 510(k) clearance for its SmartFrame OR stereotactic system.

Providence Medical Technology earned FDA clearance for its Cavux FFS-LX lumbar facet fixation system.

Medtronic received FDA approval for its deep brain stimulation system. 

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