/PRNewswire/ -- Expanding Innovations™ (EI), a rapidly growing spine company specializing in

/PRNewswire/ -- Expanding Innovations™（EI），一家快速发展的脊柱公司，专注于

NON-SCREW-based

基于非螺钉的

Expandable Technology, today announced U.S. FDA 510(k) clearance for its

可扩展技术公司今天宣布其获得了美国FDA 510(k)的批准

N-GAGE

N-GAGE

Lumbar Plate System

腰椎钢板系统

—the company's first spinal fixation platform as it continues to broaden its procedure-based solutions.

—该公司的首个脊柱固定平台，随着其不断拓宽基于手术方案的解决方案。

The modular, low-profile construct offers spine surgeons a flexible fixation solution for lateral and anterolateral lumbar fusions.

模块化、低轮廓的结构为脊柱外科医生提供了用于侧向和前外侧腰椎融合的灵活固定解决方案。

The N-GAGE

N-GAGE

Plate

盘子

uniquely pairs with the

唯一地与

X-PAC

X-PAC

LLIF Expandable Interbody Cage System

LLIF可扩张椎间融合器系统

via a

通过一个

NON-SCREW-based

基于非螺钉的

Polyaxial Coupler

多轴耦合器

. This first-of-its-kind connection simplifies plate-to-cage attachment and allows anatomical conformity to the vertebral bodies, mitigating the limitations of rigid, screw-based-attached lumbar plates.

这种首次出现的连接方式简化了板到笼的附着，并允许与椎体解剖结构相适应，减轻了基于刚性螺钉固定的腰椎板的局限性。

'This regulatory milestone not only reflects our ongoing commitment to solving persistent challenges that exist in spine surgery,' said

“这一监管里程碑不仅反映了我们对解决脊柱手术中存在的持久挑战的持续承诺，”

Ron Sacher

罗恩·萨赫尔

, Executive Chairman and Co-Founder. 'It represents the first of multiple upcoming technologies that will transition EI from a product-based technology company to a complete procedural solutions provider.

执行主席兼联合创始人。“它代表了将使EI从基于产品技术的公司过渡到完整程序解决方案供应商的多项即将推出的技术中的第一项。

N-GAGE

N-GAGE

™ unlocks new revenue opportunities and end-user value to complement our flagship,

™ 开启了新的收入机会和最终用户价值，以补充我们的旗舰产品，

NON-SCREW-based

基于非螺钉的

X-PAC®

X-PAC®

expandable technology platform.'

可扩展的技术平台。

About Expanding Innovations

关于扩展创新

Expanding Innovations™ is an emerging medical device leader in expandable implant technology for spine surgery. EI recognized the need to develop a next-generation expandable interbody cage platform that would mitigate the incidence of post-op cage collapse and vertebral body subsidence. Rising to the challenge, EI developed a revolutionary, NON-SCREW-based expandable cage that surgeons and patients can count on.

Expanding Innovations™ 是脊柱手术中可扩展植入技术的新兴医疗设备领导者。EI 意识到需要开发下一代可扩展椎间融合器平台，以减少术后融合器塌陷和椎体下沉的发生率。面对挑战，EI 开发了一种革命性的、基于非螺钉设计的可扩展融合器，医生和患者可以信赖这一产品。

X-PAC® Expandable Interbody Cages replace the traditional inner implant drive screw with a patented lift and lock expansion mechanism that provides exceptional tactile feedback to the surgeon throughout implant expansion and robust locking of the implant upon completion of expansion. With over 15,000 cages implanted, surgeon adoption and trust in X-PAC Expandable Interbody Cage technology continue to grow across .

X-PAC®可扩张椎间融合器采用获得专利的提升锁定扩展机制，取代了传统的内部植入螺钉驱动设计，该机制在植入物扩张过程中为外科医生提供卓越的手感反馈，并在扩张完成后实现牢固的锁定。凭借超过15,000个融合器的成功植入，X-PAC可扩张椎间融合器技术在中的外科医生认可度和信任度持续增长。

the United States

美国

. Expanding Innovations continues to innovate with significant technology advancements and planned expansion of its X-PAC Portfolio in 2026.

扩大创新公司继续通过重大的技术进步和计划于2026年扩展其X-PAC产品组合来进行创新。