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FDA 510(k)

Tigon Medical Button System

K-Number: K211049 · 2021-08-04

ApplicantTigon Medical
Decision Date2021-08-04
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tigon Medical Button System is a medical device manufactured by Tigon Medical. It received FDA 510(k) clearance on 2021-08-04 under approval number K211049. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tigon Medical Button System?

Tigon Medical Button System is a medical device that received FDA 510(k) clearance on 2021-08-04. It is manufactured by Tigon Medical. The 510(k) number is K211049.

When was Tigon Medical Button System approved by the FDA?

Tigon Medical Button System received FDA 510(k) clearance on 2021-08-04, under approval number K211049.

What company makes Tigon Medical Button System?

Tigon Medical Button System is manufactured by Tigon Medical.

What is the FDA product code for Tigon Medical Button System?

The FDA product code for Tigon Medical Button System is MBI.

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Tigon Medical

K182507Tigon Medical Tissue Anchors K220464Tigon Medical Gryphon Anchor Line K242529Tigon Medical All-Suture Anchors (ASA) K240175Tigon Medical Fractures, Instability, and Reconstruction (FIRE) K252596Tigon Medical Knotless and Dual Javelin All-Suture Anchors K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line

View all 7 devices →

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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