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FDA 510(k)

OsteoMed ExtremiFix Mini & Small Cannulated Screw System

K-Number: K202680 · 2020-10-15

ApplicantOsteomed, LLC
Decision Date2020-10-15
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OsteoMed ExtremiFix Mini & Small Cannulated Screw System is a medical device manufactured by Osteomed, LLC. It received FDA 510(k) clearance on 2020-10-15 under approval number K202680. 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 OsteoMed ExtremiFix Mini & Small Cannulated Screw System?

OsteoMed ExtremiFix Mini & Small Cannulated Screw System is a medical device that received FDA 510(k) clearance on 2020-10-15. It is manufactured by Osteomed, LLC. The 510(k) number is K202680.

When was OsteoMed ExtremiFix Mini & Small Cannulated Screw System approved by the FDA?

OsteoMed ExtremiFix Mini & Small Cannulated Screw System received FDA 510(k) clearance on 2020-10-15, under approval number K202680.

What company makes OsteoMed ExtremiFix Mini & Small Cannulated Screw System?

OsteoMed ExtremiFix Mini & Small Cannulated Screw System is manufactured by Osteomed, LLC.

What is the FDA product code for OsteoMed ExtremiFix Mini & Small Cannulated Screw System?

The FDA product code for OsteoMed ExtremiFix Mini & Small Cannulated Screw System is HWC. This falls under the Cardiovascular category.

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026)

Other Devices by Osteomed, LLC

K163303OsteoMed ExtremiFix Mid and Large Screw System K173391OsteoMed QuickFix Hybrid MMF Sterilization Tray K202105OsteoMed ExtremiFix Mini & Small System Tray K212570OsteoPlan System

Related Devices (Code: HWC)

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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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