Legal & Regulatory

SpinePoint Receives U.S. FDA 510(k) Clearance for Flex-Z™ Cervical Cage / First Product in the Ultra-Low Stiffness Cushioning Interbody Platform

SpinePoint LLC announced U.S. FDA 510(k) clearance of the Flex-Z™ Cervical Cage (K252432) on March 25, 2026.

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Spinal Elements Expands Ventana® Platform with FDA 510(k) Clearance and First Cases of Ventana® A ALIF System

Spinal Elements® announced 510(k) clearance from the FDA and the first cases using its Ventana A Anterior Lumbar Interbody Fusion System.

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2nd FDA Clearance for Novel Instrument Sterilization System

FDA grants a second 510(k) clearance for an expanded approved storage window in Innovative Sterilization Technologies ONE TRAY® system.

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FDA Approves (PMA) Dynamic Sagittal Tethering for Spondy

Significant PMA announcement from the FDA: Dynamic Sagittal Tethering approved for commercial sale.

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Synergy Spine Solutions® Receives FDA Approval for its Synergy Disc®, Expanding Cervical Disc Replacement Options for U.S. Patients

Synergy Spine Solutions® today announced it has received FDA Premarket Approval for the Synergy Disc® for 1-level indications at C3-C7.

4WEB Medical Receives 510(k) Clearance to Market its New SI Joint Truss System™

4WEB Medical announced that it has received 510(k) clearance to market its SI Joint Truss System™.

MiRus® Receives FDA 510(k) Clearance for IO™ Expandable Wedge Osteotomy System

MiRus® announced FDA 510(k) clearance and commercial launch of the IO™ Expandable Wedge Osteotomy System.

FDA Clears IST’s ONE TRAY® for 365 Day Storage, Expanding Sterilization Flexibility for Surgical Facilities

ONE TRAY®s NEW additional clearance in 2025 (IFU K250029**) maintains the same validated sterilization parameters – 270°F (132°C), Exposure Time 4 minutes, but with a 365 day event related shelf life/storage period with a 15-minute minimum dry time.

Medtronic’s Next Gen Intelligent Spine Platform Unveiled

Spine surgeons, gather ‘round — there’s a new system in town…and it’s not just another robot arm bolted onto a navigation cart.

Medtronic Announces FDA approval of Infuse™ bone graft for one-and-two level Transforaminal Lumbar Interbody Fusion (TLIF) spine procedures

Infuse™ is the only PMA-approved growth factor bone graft indicated for ALIF, OLIF, and TLIF.

Medtronic receives FDA clearance for Stealth AXiS™ surgical system, first integrated planning, navigation and robotics platform for spine surgery

Medtronic today announced U.S. Food and Drug Administration (FDA) clearance of the Stealth AXiS™ surgical system.

Patent Granted for Artificially Intelligent Surgical Planning

AI ortho software patent granted to 1-year old, Gainesville, Florida-based Advita Ortho.