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FDA 510(k)

Tigon Medical Fractures, Instability, and Reconstruction (FIRE)

K-Number: K240175 · 2024-10-29

ApplicantTigon Medical
Decision Date2024-10-29
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tigon Medical Fractures, Instability, and Reconstruction (FIRE) is the device name listed in this FDA 510(k) record. The listed applicant is Tigon Medical. It received FDA 510(k) clearance on 2024-10-29 under 510(k) number K240175. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tigon Medical Fractures, Instability, and Reconstruction (FIRE)?

Tigon Medical Fractures, Instability, and Reconstruction (FIRE) is a medical device that received FDA 510(k) clearance on 2024-10-29. The listed applicant is Tigon Medical. The 510(k) number is K240175.

When did Tigon Medical Fractures, Instability, and Reconstruction (FIRE) receive FDA 510(k) clearance?

Tigon Medical Fractures, Instability, and Reconstruction (FIRE) received FDA 510(k) clearance on 2024-10-29, under 510(k) number K240175.

Who is the listed applicant for Tigon Medical Fractures, Instability, and Reconstruction (FIRE)?

The FDA 510(k) record lists Tigon Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tigon Medical Fractures, Instability, and Reconstruction (FIRE)?

The FDA product code for Tigon Medical Fractures, Instability, and Reconstruction (FIRE) is HWC. This falls under the Cardiovascular category.

Other records listing Tigon Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HWC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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