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FDA 510(k)

Hand Trauma Threaded Nail System

K-Number: K230908 · 2023-04-28

ApplicantSkeletal Dynamics, Inc.
Decision Date2023-04-28
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Hand Trauma Threaded Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2023-04-28 under 510(k) 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. The listed applicant is Skeletal Dynamics, Inc.. The 510(k) number is K230908.

When did Hand Trauma Threaded Nail System receive FDA 510(k) clearance?

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

Who is the listed applicant for Hand Trauma Threaded Nail System?

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

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

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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