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FDA 510(k)

OsteoMed ExtremiFix Mini & Small System Tray

K-Number: K202105 · 2020-10-29

ApplicantOsteomed, LLC
Decision Date2020-10-29
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OsteoMed ExtremiFix Mini & Small System Tray is a medical device manufactured by Osteomed, LLC. It received FDA 510(k) clearance on 2020-10-29 under approval number K202105. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OsteoMed ExtremiFix Mini & Small System Tray?

OsteoMed ExtremiFix Mini & Small System Tray is a medical device that received FDA 510(k) clearance on 2020-10-29. It is manufactured by Osteomed, LLC. The 510(k) number is K202105.

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

OsteoMed ExtremiFix Mini & Small System Tray received FDA 510(k) clearance on 2020-10-29, under approval number K202105.

What company makes OsteoMed ExtremiFix Mini & Small System Tray?

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

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

The FDA product code for OsteoMed ExtremiFix Mini & Small System Tray is KCT.

Related Clinical Trials

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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 K202680OsteoMed ExtremiFix Mini & Small Cannulated Screw System K212570OsteoPlan System

Related Devices (Code: KCT)

K160574K3PRO SURGICAL TRAYArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG K162600Jewel Precision Reusable Rigid Sterilization Container SystemJewel Precision Sheet Metal & Machine, Inc. K160912Sterilization TraySTERIS Corporation K161347Signia sterilization trayCovidien K152745ReNew Sterilization Trays(Catalog #3708 and #3709)Microline Surgical, Inc. K152111Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc.

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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