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FDA 510(k)

Revival Modular Hip Stem

K-Number: K191374 · 2019-07-22

ApplicantCorin U.S.A. Limited
Decision Date2019-07-22
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Revival Modular Hip Stem is the device name listed in this FDA 510(k) record. The listed applicant is Corin U.S.A. Limited. It received FDA 510(k) clearance on 2019-07-22 under 510(k) number K191374. 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 Revival Modular Hip Stem?

Revival Modular Hip Stem is a medical device that received FDA 510(k) clearance on 2019-07-22. The listed applicant is Corin U.S.A. Limited. The 510(k) number is K191374.

When did Revival Modular Hip Stem receive FDA 510(k) clearance?

Revival Modular Hip Stem received FDA 510(k) clearance on 2019-07-22, under 510(k) number K191374.

Who is the listed applicant for Revival Modular Hip Stem?

The FDA 510(k) record lists Corin U.S.A. Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Revival Modular Hip Stem?

The FDA product code for Revival Modular Hip Stem is LZO.

Other records listing Corin U.S.A. Limited as applicant

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.

K242744Trinity EVO Acetabular ShellK241808ApolloHipX (THR.SS.0001)K241472Icona Hip StemK241570Unity Total Knee SystemK240875Unity Knee PS-C Tibial InsertK231172ApolloKnee

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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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