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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 the device name listed in this FDA 510(k) record. The listed applicant is Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2020-12-10 under 510(k) 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. The listed applicant is Microport Orthopedics, Inc.. The 510(k) number is K201519.

When did PROFEMUR® GLADIATOR® Cemented Classic Stem receive FDA 510(k) clearance?

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

Who is the listed applicant for PROFEMUR® GLADIATOR® Cemented Classic Stem?

The FDA 510(k) record lists Microport Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Microport Orthopedics, Inc. as applicant

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Related Devices (Code: JDI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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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