4WEB Medical receives FDA 510(k) clearances for integrated cervical plating system
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Key takeaways:
- 4WEB Medical received FDA clearance of the Cervical Spine Truss System integrated plating solution.
- The company also received clearance of two cervical interbody line extensions.
4WEB Medical has announced FDA 510(k) clearance of the Cervical Spine Truss System integrated plating solution, as well as two cervical interbody line extensions, according to a press release.
The Cervical Spine Truss System (CSTS) integrated plating solution is designed for patients undergoing cervical interbody fusion, according to the release. Additionally, the FDA clearance included two cervical interbody line extensions with implants for various degrees of lordosis and an option for a large footprint, according to the release.
“The CSTS integrated plating solution provides an additional stand-alone treatment option for 4WEB’s surgeon customers,” Jonathan Hires, director of research and development at 4WEB Medical, said in the release. “With two product launches in [the third quarter] and regulatory clearance for the integrated plate, we have built significant momentum towards completing the company’s comprehensive cervical portfolio by the end of the year,” Hires said.
“The launch of the CSTS integrated plating solution builds on an already robust product portfolio,” Geoff Bigos, vice president of the spine division at 4WEB Medical, said in the release. “We are excited to launch several new cervical products before the end of the year and look forward to capitalizing on this success with significant growth in 2024,” Bigos added.
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