PrinterPrezz Receives 510(k) Clearance for New Family of 3D Printed Spine Devices

FREMONT, CA, UNITED STATES, October 13, 2020 / — PrinterPrezz, Inc., a trailblazer in medical polymer and metal 3D printing, nanotechnologies and implant design, today announced the U.S. Food and Drug Administration (FDA) clearance of the company’s 510(k) for the PrinterPrezz GAIA™ Lumbar Interbody Fusion Device (LIFD) family of spine implants as a reference platform for future medical device innovators. The first implant systems announced today under the GAIA™ platform include the Astraeus ALIF, Themis TPLIF, and Prometheus PLIF systems. Market introduction plans have not yet been finalized.

“The products announced today represent our cumulative learnings in medical device design, additive manufacturing processes, non-active implantable medical device (NAIMD) testing, cleaning, packaging & sterilization, and quality management,” said Shri Shetty, CEO of PrinterPrezz. “What makes GAIA™ a true reference platform, and PrinterPrezz a true medical device foundry, is that our customers have access to the array of technologies developed and validated during the GAIA™ program for their own product lines. Experienced customers benefit from our 3D print and design optimizations that help reduce manufacturing costs, while small, and mid-size customers may find benefit leveraging our FDA documentation.”

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