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FDA 510(k)

MicroPort Orthopedics Total Hip Systems MR Labeling

K-Number: K173898 · 2018-09-20

ApplicantMicroport Orthopedics Inc. (Mpo)
Decision Date2018-09-20
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MicroPort Orthopedics Total Hip Systems MR Labeling is the device name listed in this FDA 510(k) record. The listed applicant is Microport Orthopedics Inc. (Mpo). It received FDA 510(k) clearance on 2018-09-20 under 510(k) number K173898. 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 MicroPort Orthopedics Total Hip Systems MR Labeling?

MicroPort Orthopedics Total Hip Systems MR Labeling is a medical device that received FDA 510(k) clearance on 2018-09-20. The listed applicant is Microport Orthopedics Inc. (Mpo). The 510(k) number is K173898.

When did MicroPort Orthopedics Total Hip Systems MR Labeling receive FDA 510(k) clearance?

MicroPort Orthopedics Total Hip Systems MR Labeling received FDA 510(k) clearance on 2018-09-20, under 510(k) number K173898.

Who is the listed applicant for MicroPort Orthopedics Total Hip Systems MR Labeling?

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

What is the FDA product code for MicroPort Orthopedics Total Hip Systems MR Labeling?

The FDA product code for MicroPort Orthopedics Total Hip Systems MR Labeling is LZO.

Related Devices (Code: LZO)

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.

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbHK252401implaFit® short stemsImplantcast GmbHK253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx 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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