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FDA 510(k)

Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads

K-Number: K173499 · 2018-03-19

ApplicantStryker Orthopaedics
Decision Date2018-03-19
Product CodeJDG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Orthopaedics. It received FDA 510(k) clearance on 2018-03-19 under 510(k) number K173499. The device is classified under product code JDG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads?

Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads is a medical device that received FDA 510(k) clearance on 2018-03-19. The listed applicant is Stryker Orthopaedics. The 510(k) number is K173499.

When did Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads receive FDA 510(k) clearance?

Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads received FDA 510(k) clearance on 2018-03-19, under 510(k) number K173499.

Who is the listed applicant for Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads?

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

What is the FDA product code for Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads?

The FDA product code for Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads is JDG.

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.

NCT05144191Insignia™ Hip Stem Outcomes StudyACTIVE_NOT_RECRUITINGNCT02521103Triathlon Tritanium Cone Augments Outcomes StudyACTIVE_NOT_RECRUITINGNCT02999009Trident II Tritanium Acetabular Shell Outcomes StudyACTIVE_NOT_RECRUITINGNCT05591859Restoration Anatomic Acetabular Shell Revision StudyWITHDRAWNNCT07647354Mako-MORE RegistryRECRUITINGNCT07616895MFinity BE Pre-market TrialNOT_YET_RECRUITING

Other records listing Stryker Orthopaedics 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.

K211703Insignia Hip StemK191414EXETER Centralizer, EXETER 2.5mm PlugK173849Triathlon Total Knee SystemK172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemK153345Stryker Orthopaedics Hip Systems Labeling Update

Related Devices (Code: JDG)

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.

K212431Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveBiomet, Inc.K193546Distal CentralizersBiomet, 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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