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 a medical device manufactured by Nvision Biomedical Technologies. It received FDA 510(k) clearance on 2025-02-05 under approval 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. It is manufactured by Nvision Biomedical Technologies. The 510(k) number is K242896.
When was Caliber Intramedullary Fixation System approved by the FDA?
Caliber Intramedullary Fixation System received FDA 510(k) clearance on 2025-02-05, under approval number K242896.
What company makes Caliber Intramedullary Fixation System?
Caliber Intramedullary Fixation System is manufactured by Nvision Biomedical Technologies.
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.