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FDA 510(k)

Affixus Tibial and Antegrade Femoral Nailing System

K-Number: K241651 · 2024-09-26

ApplicantZimmer, Inc.
Decision Date2024-09-26
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Affixus Tibial and Antegrade Femoral Nailing System is a medical device manufactured by Zimmer, Inc.. It received FDA 510(k) clearance on 2024-09-26 under approval number K241651. 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 Affixus Tibial and Antegrade Femoral Nailing System?

Affixus Tibial and Antegrade Femoral Nailing System is a medical device that received FDA 510(k) clearance on 2024-09-26. It is manufactured by Zimmer, Inc.. The 510(k) number is K241651.

When was Affixus Tibial and Antegrade Femoral Nailing System approved by the FDA?

Affixus Tibial and Antegrade Femoral Nailing System received FDA 510(k) clearance on 2024-09-26, under approval number K241651.

What company makes Affixus Tibial and Antegrade Femoral Nailing System?

Affixus Tibial and Antegrade Femoral Nailing System is manufactured by Zimmer, Inc..

What is the FDA product code for Affixus Tibial and Antegrade Femoral Nailing System?

The FDA product code for Affixus Tibial and Antegrade Femoral Nailing System is HSB.

Related Clinical Trials

NCT05019664 Affixus Natural Nail System Humeral Nail PMCF ACTIVE_NOT_RECRUITING NCT07456865 Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device RECRUITING NCT03153449 ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT04358601 All-poly Versus Metal-backed ACTIVE_NOT_RECRUITING 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

Other Devices by Zimmer, Inc.

K161830Zimmer M/L Taper Hip Prosthesis K151716Cable-Ready Cable Grip System: Cable-Ready Bone Plate System K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System K172767Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid K172114Zimmer Natural Nail System K181761Zimmer Biomet Select Ceramic Heads

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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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