Threadstone LLC Regulatory Information
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FDA Approved
Threadstone holds several 510(k) clearances for its suture and suture tape products.
ISO 13485:2016 Certified
ISO 13485 sets global standards for medical device quality management systems. It ensures regulatory compliance, boosts product safety, reliability, and customer trust. Threadstone's certification demonstrates a commitment to top-tier standards and dedication to patient safety in medical device manufacturing.
The scope of ISO 13485:2016 requirements includes: Design, Manufacture and Packaging of Sutures, Fastener, Fixation, Nondegradable, Soft Tissue and Anchor.