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FDA 510(k)

PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar

K-Number: K200007 · 2020-04-25

ApplicantMicroport Orthopedics, Inc.
Decision Date2020-04-25
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar is a medical device manufactured by Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2020-04-25 under approval number K200007. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar?

PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar is a medical device that received FDA 510(k) clearance on 2020-04-25. It is manufactured by Microport Orthopedics, Inc.. The 510(k) number is K200007.

When was PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar approved by the FDA?

PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar received FDA 510(k) clearance on 2020-04-25, under approval number K200007.

What company makes PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar?

PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar is manufactured by Microport Orthopedics, Inc..

What is the FDA product code for PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar?

The FDA product code for PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar is LZO.

Other Devices by Microport Orthopedics, Inc.

K152631MPO Total Knee Systems MR Labeling K171181PROCOTYL® PRIME E-CLASS™ XLPE Liner K171389EVOLUTION Revision CCK System K170444PROCOTYL® PRIME Acetabular Cup System K170288BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell K162026EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions

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Related Devices (Code: LZO)

K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADKyocera Medical Corporation K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc. K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH K152893Corin Optimized Positioning System (OPS)Corin USA K160289MasterLoc StemMedacta International K152903REVIVAL(TM) Modular Revision Hip StemCorin USA

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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