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FDA 510(k)

ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP

K-Number: K062920 · 2006-11-13

ApplicantOrthofix Srl
Decision Date2006-11-13
Product CodeKTW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix Srl. It received FDA 510(k) clearance on 2006-11-13 under 510(k) number K062920. The device is classified under product code KTW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP?

ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP is a medical device that received FDA 510(k) clearance on 2006-11-13. The listed applicant is Orthofix Srl. The 510(k) number is K062920.

When did ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP receive FDA 510(k) clearance?

ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP received FDA 510(k) clearance on 2006-11-13, under 510(k) number K062920.

Who is the listed applicant for ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP?

The FDA 510(k) record lists Orthofix Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP?

The FDA product code for ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP is KTW.

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Other records listing Orthofix Srl as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMK253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAK250112FitboneTM TrochantericK242270OrthoNext Platform SystemK242861TrueLok ElevateK233867Fitbone Trochanteric

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Related Devices (Code: KTW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182285PK High Tibial Osteotomy Correction SystemPaonan Biotech Co., Ltd.K171606AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. (Aos)K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.K160409AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc.K122541ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)Orthofix SrlK080590AOS PROXIMAL HUMERAL PLATEAdvanced Orthopaedic Solutions, Inc.

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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