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 a medical device manufactured by Extremity Medical, LLC. It received FDA 510(k) clearance on 2020-07-08 under approval 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. It is manufactured by Extremity Medical, LLC. The 510(k) number is K201556.
When was Intraosseous Fixation System approved by the FDA?
Intraosseous Fixation System received FDA 510(k) clearance on 2020-07-08, under approval number K201556.
What company makes Intraosseous Fixation System?
Intraosseous Fixation System is manufactured by Extremity Medical, LLC.
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.
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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.