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FDA 510(k)

OsteoMed ExtremiFix Mid and Large Screw System

K-Number: K163303 · 2017-04-04

ApplicantOsteomed, LLC
Decision Date2017-04-04
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OsteoMed ExtremiFix Mid and Large Screw System is a medical device manufactured by Osteomed, LLC. It received FDA 510(k) clearance on 2017-04-04 under approval number K163303. 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 Mid and Large Screw System?

OsteoMed ExtremiFix Mid and Large Screw System is a medical device that received FDA 510(k) clearance on 2017-04-04. It is manufactured by Osteomed, LLC. The 510(k) number is K163303.

When was OsteoMed ExtremiFix Mid and Large Screw System approved by the FDA?

OsteoMed ExtremiFix Mid and Large Screw System received FDA 510(k) clearance on 2017-04-04, under approval number K163303.

What company makes OsteoMed ExtremiFix Mid and Large Screw System?

OsteoMed ExtremiFix Mid and Large Screw System is manufactured by Osteomed, LLC.

What is the FDA product code for OsteoMed ExtremiFix Mid and Large Screw System?

The FDA product code for OsteoMed ExtremiFix Mid and Large Screw System is HWC. This falls under the Cardiovascular category.

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Other Devices by Osteomed, LLC

K173391OsteoMed QuickFix Hybrid MMF Sterilization Tray K202105OsteoMed ExtremiFix Mini & Small System Tray K202680OsteoMed ExtremiFix Mini & Small Cannulated Screw System 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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