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FDA 510(k)

NOVEL TAPERED HIP STEM

K-Number: K103479 · 2011-03-10

ApplicantStryker Corp.
Decision Date2011-03-10
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NOVEL TAPERED HIP STEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corp.. It received FDA 510(k) clearance on 2011-03-10 under 510(k) number K103479. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVEL TAPERED HIP STEM?

NOVEL TAPERED HIP STEM is a medical device that received FDA 510(k) clearance on 2011-03-10. The listed applicant is Stryker Corp.. The 510(k) number is K103479.

When did NOVEL TAPERED HIP STEM receive FDA 510(k) clearance?

NOVEL TAPERED HIP STEM received FDA 510(k) clearance on 2011-03-10, under 510(k) number K103479.

Who is the listed applicant for NOVEL TAPERED HIP STEM?

The FDA 510(k) record lists Stryker Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NOVEL TAPERED HIP STEM?

The FDA product code for NOVEL TAPERED HIP STEM is MEH.

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Other records listing Stryker Corp. as applicant

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Related Devices (Code: MEH)

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.

K261576Icona Hip StemCorin, Ltd.K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KGK251166Mfinity Femoral SystemMedacta International S.A.K251052Trivicta® Hip StemOrtho Development Corp.K242315Resolve Modular Revision Hip StemUnited Orthopedic CorporationK243839Alteon® HA Femoral StemsExactech, 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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