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FDA 510(k)

Caliber Intramedullary Fixation System

K-Number: K242896 · 2025-02-05

ApplicantNvision Biomedical Technologies
Decision Date2025-02-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Caliber Intramedullary Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies. It received FDA 510(k) clearance on 2025-02-05 under 510(k) number K242896. 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 Caliber Intramedullary Fixation System?

Caliber Intramedullary Fixation System is a medical device that received FDA 510(k) clearance on 2025-02-05. The listed applicant is Nvision Biomedical Technologies. The 510(k) number is K242896.

When did Caliber Intramedullary Fixation System receive FDA 510(k) clearance?

Caliber Intramedullary Fixation System received FDA 510(k) clearance on 2025-02-05, under 510(k) number K242896.

Who is the listed applicant for Caliber Intramedullary Fixation System?

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

What is the FDA product code for Caliber Intramedullary Fixation System?

The FDA product code for Caliber Intramedullary Fixation System is HWC. This falls under the Cardiovascular category.

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Official Source

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

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