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FDA 510(k)

Affixus Tibial Nailing System - 4mm screws

K-Number: K243907 · 2025-02-12

ApplicantZimmer, Inc.
Decision Date2025-02-12
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Affixus Tibial Nailing System - 4mm screws is a medical device manufactured by Zimmer, Inc.. It received FDA 510(k) clearance on 2025-02-12 under approval number K243907. 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 Nailing System - 4mm screws?

Affixus Tibial Nailing System - 4mm screws is a medical device that received FDA 510(k) clearance on 2025-02-12. It is manufactured by Zimmer, Inc.. The 510(k) number is K243907.

When was Affixus Tibial Nailing System - 4mm screws approved by the FDA?

Affixus Tibial Nailing System - 4mm screws received FDA 510(k) clearance on 2025-02-12, under approval number K243907.

What company makes Affixus Tibial Nailing System - 4mm screws?

Affixus Tibial Nailing System - 4mm screws is manufactured by Zimmer, Inc..

What is the FDA product code for Affixus Tibial Nailing System - 4mm screws?

The FDA product code for Affixus Tibial Nailing System - 4mm screws 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 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 NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED

Other Devices by Zimmer, Inc.

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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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