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FDA 510(k)

PROFEMUR® GLADIATOR® Cemented Classic Stem

K-Number: K201519 · 2020-12-10

ApplicantMicroport Orthopedics, Inc.
Decision Date2020-12-10
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROFEMUR® GLADIATOR® Cemented Classic Stem is a medical device manufactured by Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2020-12-10 under approval number K201519. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROFEMUR® GLADIATOR® Cemented Classic Stem?

PROFEMUR® GLADIATOR® Cemented Classic Stem is a medical device that received FDA 510(k) clearance on 2020-12-10. It is manufactured by Microport Orthopedics, Inc.. The 510(k) number is K201519.

When was PROFEMUR® GLADIATOR® Cemented Classic Stem approved by the FDA?

PROFEMUR® GLADIATOR® Cemented Classic Stem received FDA 510(k) clearance on 2020-12-10, under approval number K201519.

What company makes PROFEMUR® GLADIATOR® Cemented Classic Stem?

PROFEMUR® GLADIATOR® Cemented Classic Stem is manufactured by Microport Orthopedics, Inc..

What is the FDA product code for PROFEMUR® GLADIATOR® Cemented Classic Stem?

The FDA product code for PROFEMUR® GLADIATOR® Cemented Classic Stem is JDI.

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: JDI)

K160923REDAPT Anteverted Cemented LinerSmith & Nephew, Inc. K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc. K153725Corin TaperFit Hip StemCorin U.S.A. Limited K153216Alpine Cemented Hip SystemOrtho Development Corporation K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc. K180973Libertas Hip Replacement SystemMaxx Orthopedics, 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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