FDA grants clearances for trio of VySpine products
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Key takeaways:
- VySpine received FDA clearances regarding its VyLam, VySpan and VyLink screw systems.
- The VyLam is indicated for use in laminoplasty of the lower cervical and upper thoracic spine of skeletally mature patients.
VySpine has announced FDA clearances regarding its VyLam, VySpan and VyLink screw systems, expanding the portfolio of the company.
A 510(k) clearance was granted for the VyLam system, which is indicated for use in skeletally mature patients undergoing laminoplasty of the lower cervical and upper thoracic spine (C3-T3), according to a company press release.
The VySpan posterior cervical thoracic system received clearance for additional connectors that can be attached to the VyLink screw system, which was also cleared for additional indications, according to the release.
“This is just the beginning of the exciting, innovative product launches we have scheduled for early 2024,” Bret Berry, president of product development for VySpine, said in the release.
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