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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 a medical device manufactured by Stryker Orthopaedics. It received FDA 510(k) clearance on 2018-03-19 under approval 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. It is manufactured by Stryker Orthopaedics. The 510(k) number is K173499.

When was Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads approved by the FDA?

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

What company makes Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads?

Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads is manufactured by Stryker Orthopaedics.

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

NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT07554976 Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures RECRUITING NCT05523635 Post Market Clinical Evaluation of Gamma 4 COMPLETED NCT03720782 Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty ACTIVE_NOT_RECRUITING NCT06215469 Portable Scalp Cooling System (PSCS) to Prevent Hair Loss for Breast Cancer Patients (Cooler Heads) ACTIVE_NOT_RECRUITING NCT07019662 Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach RECRUITING

Other Devices by Stryker Orthopaedics

K153345Stryker Orthopaedics Hip Systems Labeling Update K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System K173849Triathlon Total Knee System K191414EXETER Centralizer, EXETER 2.5mm Plug K211703Insignia Hip Stem

Related Devices (Code: JDG)

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