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FDA 510(k)

Intraosseous Fixation System

K-Number: K201556 · 2020-07-08

ApplicantExtremity Medical, LLC
Decision Date2020-07-08
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Intraosseous Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Extremity Medical, LLC. It received FDA 510(k) clearance on 2020-07-08 under 510(k) number K201556. 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 Intraosseous Fixation System?

Intraosseous Fixation System is a medical device that received FDA 510(k) clearance on 2020-07-08. The listed applicant is Extremity Medical, LLC. The 510(k) number is K201556.

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

Intraosseous Fixation System received FDA 510(k) clearance on 2020-07-08, under 510(k) number K201556.

Who is the listed applicant for Intraosseous Fixation System?

The FDA 510(k) record lists Extremity Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intraosseous Fixation System?

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

Other records listing Extremity Medical, LLC as applicant

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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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