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FDA 510(k)

TheRay Collared and Collarless Femoral Stem

K-Number: K241875 · 2024-09-13

ApplicantNextstep Arthropedix
Decision Date2024-09-13
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TheRay Collared and Collarless Femoral Stem is the device name listed in this FDA 510(k) record. The listed applicant is Nextstep Arthropedix. It received FDA 510(k) clearance on 2024-09-13 under 510(k) number K241875. 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 TheRay Collared and Collarless Femoral Stem?

TheRay Collared and Collarless Femoral Stem is a medical device that received FDA 510(k) clearance on 2024-09-13. The listed applicant is Nextstep Arthropedix. The 510(k) number is K241875.

When did TheRay Collared and Collarless Femoral Stem receive FDA 510(k) clearance?

TheRay Collared and Collarless Femoral Stem received FDA 510(k) clearance on 2024-09-13, under 510(k) number K241875.

Who is the listed applicant for TheRay Collared and Collarless Femoral Stem?

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

What is the FDA product code for TheRay Collared and Collarless Femoral Stem?

The FDA product code for TheRay Collared and Collarless Femoral Stem is MEH.

Related Clinical Trials

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.

NCT07616895MFinity BE Pre-market TrialNOT_YET_RECRUITING

Other records listing Nextstep Arthropedix 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.

K242410NextStep Arthropedix Total Knee System

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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