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FDA 510(k)

DePuy Synthes Femoral Neck System

K-Number: K172872 · 2018-03-05

ApplicantDePuy Synthes
Decision Date2018-03-05
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DePuy Synthes Femoral Neck System is a medical device manufactured by DePuy Synthes. It received FDA 510(k) clearance on 2018-03-05 under approval number K172872. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DePuy Synthes Femoral Neck System?

DePuy Synthes Femoral Neck System is a medical device that received FDA 510(k) clearance on 2018-03-05. It is manufactured by DePuy Synthes. The 510(k) number is K172872.

When was DePuy Synthes Femoral Neck System approved by the FDA?

DePuy Synthes Femoral Neck System received FDA 510(k) clearance on 2018-03-05, under approval number K172872.

What company makes DePuy Synthes Femoral Neck System?

DePuy Synthes Femoral Neck System is manufactured by DePuy Synthes.

What is the FDA product code for DePuy Synthes Femoral Neck System?

The FDA product code for DePuy Synthes Femoral Neck System is KTT.

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 NCT07019662 Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach RECRUITING NCT06368700 The HYALEX Pivotal Study RECRUITING

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Related Devices (Code: KTT)

K160972Gexfix External FixationGexfix International Corp. K161753Hoffman LRF SystemStryker GmbH K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC K160830Integra External Fixation SystemAscension Orthopedics K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH K151881X-Fix Line AdditionsVilex IN Tennessee, 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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