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FDA 510(k)

EBA One Nailing System

K-Number: K183666 · 2019-11-14

ApplicantCitieffe S.R.L.
Decision Date2019-11-14
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EBA One Nailing System is a medical device manufactured by Citieffe S.R.L.. It received FDA 510(k) clearance on 2019-11-14 under approval number K183666. 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 EBA One Nailing System?

EBA One Nailing System is a medical device that received FDA 510(k) clearance on 2019-11-14. It is manufactured by Citieffe S.R.L.. The 510(k) number is K183666.

When was EBA One Nailing System approved by the FDA?

EBA One Nailing System received FDA 510(k) clearance on 2019-11-14, under approval number K183666.

What company makes EBA One Nailing System?

EBA One Nailing System is manufactured by Citieffe S.R.L..

What is the FDA product code for EBA One Nailing System?

The FDA product code for EBA One Nailing System is HSB.

Related Clinical Trials

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 Citieffe S.R.L.

K163323Dolphix® External Fixation System MR Conditional K180150PL8 Wrist Reconstruction Plate K181540Estremo Citieffe Nailing System K250197Estremo Fibular Nail

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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