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FDA 510(k)

Elos® Intramedullary Nailing System

K-Number: K201147 · 2021-07-19

ApplicantIntrauma S.P.A
Decision Date2021-07-19
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Elos® Intramedullary Nailing System is a medical device manufactured by Intrauma S.P.A. It received FDA 510(k) clearance on 2021-07-19 under approval number K201147. 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 Elos® Intramedullary Nailing System?

Elos® Intramedullary Nailing System is a medical device that received FDA 510(k) clearance on 2021-07-19. It is manufactured by Intrauma S.P.A. The 510(k) number is K201147.

When was Elos® Intramedullary Nailing System approved by the FDA?

Elos® Intramedullary Nailing System received FDA 510(k) clearance on 2021-07-19, under approval number K201147.

What company makes Elos® Intramedullary Nailing System?

Elos® Intramedullary Nailing System is manufactured by Intrauma S.P.A.

What is the FDA product code for Elos® Intramedullary Nailing System?

The FDA product code for Elos® Intramedullary Nailing System is HSB.

Related Clinical Trials

NCT07569575 Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures NOT_YET_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 Intrauma S.P.A

K230623KITE Distal Fibula Kit K252959WRISTAR MultiAx Distal Radius Kit

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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