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FDA 510(k)

Apex Tibial Nailing System

K-Number: K170972 · 2017-12-20

ApplicantOrthoxel
Decision Date2017-12-20
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Apex Tibial Nailing System is a medical device manufactured by Orthoxel. It received FDA 510(k) clearance on 2017-12-20 under approval number K170972. 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 Tibial Nailing System?

Apex Tibial Nailing System is a medical device that received FDA 510(k) clearance on 2017-12-20. It is manufactured by Orthoxel. The 510(k) number is K170972.

When was Apex Tibial Nailing System approved by the FDA?

Apex Tibial Nailing System received FDA 510(k) clearance on 2017-12-20, under approval number K170972.

What company makes Apex Tibial Nailing System?

Apex Tibial Nailing System is manufactured by Orthoxel.

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

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

Related Clinical Trials

NCT07456865 Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device RECRUITING NCT04358601 All-poly Versus Metal-backed ACTIVE_NOT_RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT03720782 Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty ACTIVE_NOT_RECRUITING NCT04015128 A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GT ACTIVE_NOT_RECRUITING NCT04015154 A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail PF COMPLETED

Other Devices by Orthoxel

K181375Apex Femoral 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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