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Elevation Spine Receives FDA 510(k) Clearance for Saber-C® AVIA™, A Complete Anterior Cervical Fixation System with a Porous 3D-Printed Titanium Interbody

MONTEREY, Calif.--(BUSINESS WIRE)--Elevation Spine today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) Clearance for Saber-C® AVIA™, the newest product line in the Saber platform. Saber-C AVIA is engineered as a zero-profile anterior cervical discectomy and fusion (ACDF) construct with the biomechanical stability historically associated with traditional plating and features a porous 3D-printed titanium interbody with both spike and screw fixation options.

"Our dedicated Saber-C surgeon community gave us valuable feedback, and those conversations shaped what came next," said Charlie Gilbride, CEO of Elevation Spine. "We focused on purposeful instrumentation, a porous 3D titanium implant supported by preclinical research, and thoughtful refinements that build on the strengths of the original platform. Our size is one of our greatest advantages. We stay close to our surgeon network, move quickly on their feedback, and remain focused on delivering meaningful innovation where it matters most."

The new system design provides a slim, lower-profile workflow, with additions and refinements across multiple instruments. The majority of the core Saber-C spike instruments have been updated for more precise spike delivery, while new Saber-C screw instruments have been added, including a very low-profile screw inserter. Saber-C AVIA ships with both spike and screw instrumentation in a single tray for every case, offering maximum versatility in the operating room. The result is a system that can help support a full range of ACDF cases, all in one kit.

The porous 3D-printed titanium interbody has a 55% porosity lattice architecture engineered to mimic trabecular bone. The porous structure of Saber-C AVIA is associated with bone ingrowth in preclinical data1. The implant is available in 6° lordotic and 12° hyperlordotic options with a large central graft window.

Saber-C AVIA is available immediately for surgical use in the United States.

1. Data on file

About Elevation Spine

Elevation Spine, headquartered in Monterey, CA, is the leading spinal medical device developer of integrated-fixation technologies. The Saber Technology platform integrates zero-profile, anterior cervical plate fixation with interbody support in the cervical spine. Saber systems are designed to simplify surgical workflow while improving patient outcomes.

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Contacts

Media Contact: Martin Klazmer | martinklazmer@elevationspine.com

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Elevation Spine

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Contacts

Media Contact: Martin Klazmer | martinklazmer@elevationspine.com

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