FDA 510(k)

Estremo Fibular Nail

K-Number: K250197 · 2025-10-17

Decision Date2025-10-17

Product CodeHSB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Estremo Fibular Nail is a medical device manufactured by Citieffe S.R.L.. It received FDA 510(k) clearance on 2025-10-17 under approval number K250197. 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 Estremo Fibular Nail?

Estremo Fibular Nail is a medical device that received FDA 510(k) clearance on 2025-10-17. It is manufactured by Citieffe S.R.L.. The 510(k) number is K250197.

When was Estremo Fibular Nail approved by the FDA?

Estremo Fibular Nail received FDA 510(k) clearance on 2025-10-17, under approval number K250197.

What company makes Estremo Fibular Nail?

Estremo Fibular Nail is manufactured by Citieffe S.R.L..

What is the FDA product code for Estremo Fibular Nail?

The FDA product code for Estremo Fibular Nail is HSB.

Other Devices by Citieffe S.R.L.

K163323Dolphix® External Fixation System MR Conditional K180150PL8 Wrist Reconstruction Plate K183666EBA One Nailing System K181540Estremo Citieffe 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.