Life Spine Announces FDA 510(k) Clearance for the GRUVE® + Cervical Plating System
Life Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market GRUVE + Cervical Plating System.
GRUVE + (plus) Cervical Plating System establishes a new standard in spinal surgery through its advanced design and seamless integration with Life Spine's cervical spacers. Engineered for versatility and precision, it addresses the diverse needs of surgeons and patients, enhancing surgical efficiency and outcomes. This innovation reflects Life Spine's commitment to delivering cutting-edge solutions for superior spine care.
Key Features and Benefits:
Streamlined Plate-Cage Attachment: Flexible connection in-situ or prior to insertion.
Specialized Sub-Flush Design: Accommodates osteophytes for improved comfort.
Customizable Plate Options: 2-hole and 4-hole configurations for anatomical preferences.
Self-Drilling/Self-Tapping Screws: High angulation trajectory for varied anatomies.
CAM Locking Mechanism: Triple feedback (visual, tactile, audible) to secure screws and prevent back-out.
Compatibility: Integrates with PLATEAU ® -C/PLATEAU-C Ti and Pro-Link ® /Pro-Link Ti platforms.
Large Graft Window: Maximizes material containment for robust fusion.
'This FDA 510(k) clearance marks a significant milestone,' said Mariusz Knap, Senior Vice President of Marketing. 'GRUVE + offers seamless plate/cage attachment and delivers the precision, safety, and adaptability surgeons demand while improving outcomes for patients.'
About Life Spine, Inc.
Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.
SOURCE: Life Spine, Inc.
Copyright Business Wire 2025.
PUB: 02/18/2025 12:07 PM/DISC: 02/18/2025 12:07 PM
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