MetaFore Small Screw System
K-Number: K250536 · 2025-10-08
ApplicantExtremity Medical, LLC
Decision Date2025-10-08
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
MetaFore Small Screw System is a medical device manufactured by Extremity Medical, LLC. It received FDA 510(k) clearance on 2025-10-08 under approval number K250536. 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 MetaFore Small Screw System?
MetaFore Small Screw System is a medical device that received FDA 510(k) clearance on 2025-10-08. It is manufactured by Extremity Medical, LLC. The 510(k) number is K250536.
When was MetaFore Small Screw System approved by the FDA?
MetaFore Small Screw System received FDA 510(k) clearance on 2025-10-08, under approval number K250536.
What company makes MetaFore Small Screw System?
MetaFore Small Screw System is manufactured by Extremity Medical, LLC.
What is the FDA product code for MetaFore Small Screw System?
The FDA product code for MetaFore Small Screw 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.