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FDA 510(k)

SnapHammer Hammertoe Correction System

K-Number: K250613 · 2025-04-02

ApplicantNvision Biomedical Technologies, Inc.
Decision Date2025-04-02
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SnapHammer Hammertoe Correction System is the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2025-04-02 under 510(k) number K250613. 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 SnapHammer Hammertoe Correction System?

SnapHammer Hammertoe Correction System is a medical device that received FDA 510(k) clearance on 2025-04-02. The listed applicant is Nvision Biomedical Technologies, Inc.. The 510(k) number is K250613.

When did SnapHammer Hammertoe Correction System receive FDA 510(k) clearance?

SnapHammer Hammertoe Correction System received FDA 510(k) clearance on 2025-04-02, under 510(k) number K250613.

Who is the listed applicant for SnapHammer Hammertoe Correction System?

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

What is the FDA product code for SnapHammer Hammertoe Correction System?

The FDA product code for SnapHammer Hammertoe Correction 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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