FDA 510(k)

Hand Trauma Threaded Nail System

K-Number: K230908 · 2023-04-28

Decision Date2023-04-28

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Hand Trauma Threaded Nail System is a medical device manufactured by Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2023-04-28 under approval number K230908. 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 Hand Trauma Threaded Nail System?

Hand Trauma Threaded Nail System is a medical device that received FDA 510(k) clearance on 2023-04-28. It is manufactured by Skeletal Dynamics, Inc.. The 510(k) number is K230908.

When was Hand Trauma Threaded Nail System approved by the FDA?

Hand Trauma Threaded Nail System received FDA 510(k) clearance on 2023-04-28, under approval number K230908.

What company makes Hand Trauma Threaded Nail System?

Hand Trauma Threaded Nail System is manufactured by Skeletal Dynamics, Inc..

What is the FDA product code for Hand Trauma Threaded Nail System?

The FDA product code for Hand Trauma Threaded Nail 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.