7 New Spine, Orthopedic Device Launches & Approvals

Spine

Here are seven orthopedic and spine device that recently received FDA approval or were recently launched.

Austin, Texas-based LDR received FDA approval for the commercial sale and distribution of the Mobi-C Cervical Disc for one-level indications.

 

Stryker received 510(k) clearance for two devices in its minimally invasive spine portfolio, the Venom RF Cannula and Electrode and 11g iVAS Balloon System for treating facet joint pain.

 

Mizuho OSI launched the proAXIS Spinal Surgery Table, featuring software-controlled hinge technology.

 

Silicon Valley, Calif.-based NDS Surgical Imaging, a manufacturer of medical imaging and informatics systems, announced the release of DomeAccess, its new remote PACS systems management software tool.

 

The FDA awarded 510(k) clearance to Plainsboro, N.J.-based Integra LifeSciences' Integra Titan Reverse Shoulder System.

 

Carlsbad, Calif.-based Aurora Spine received European CE Mark for its ZIP MIS Interspinous Fusion System.

 

Austin, Texas-based Ortho Kinematics received FDA 510(k) clearance to offer the Vertebral Motion Analysis system for cervical spine in addition to already-cleared use for lumbar spine.

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