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FDA 510(k)

Apex Femoral Nailing System

K-Number: K181375 · 2018-07-17

ApplicantOrthoxel
Decision Date2018-07-17
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Apex Femoral Nailing System is a medical device manufactured by Orthoxel. It received FDA 510(k) clearance on 2018-07-17 under approval number K181375. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Apex Femoral Nailing System?

Apex Femoral Nailing System is a medical device that received FDA 510(k) clearance on 2018-07-17. It is manufactured by Orthoxel. The 510(k) number is K181375.

When was Apex Femoral Nailing System approved by the FDA?

Apex Femoral Nailing System received FDA 510(k) clearance on 2018-07-17, under approval number K181375.

What company makes Apex Femoral Nailing System?

Apex Femoral Nailing System is manufactured by Orthoxel.

What is the FDA product code for Apex Femoral Nailing System?

The FDA product code for Apex Femoral Nailing System is HSB.

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

Other Devices by Orthoxel

K170972Apex Tibial Nailing System

Related Devices (Code: HSB)

K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc. K160545GAP ENDO-EXO MEDULLARY SYSTEMPega Medical, Inc. K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. K160267PRECICE Trauma Nail SystemEllipse Technologies, Incorporated

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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