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FDA 510(k)

ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)

K-Number: K122541 · 2012-09-20

ApplicantOrthofix Srl
Decision Date2012-09-20
Product CodeKTW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix Srl. It received FDA 510(k) clearance on 2012-09-20 under 510(k) number K122541. 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 CONTOURS PROIMAL HUMERAL PLATE (PHP)?

ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) is a medical device that received FDA 510(k) clearance on 2012-09-20. The listed applicant is Orthofix Srl. The 510(k) number is K122541.

When did ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) receive FDA 510(k) clearance?

ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) received FDA 510(k) clearance on 2012-09-20, under 510(k) number K122541.

Who is the listed applicant for ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)?

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 CONTOURS PROIMAL HUMERAL PLATE (PHP)?

The FDA product code for ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) is KTW.

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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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.K080590AOS PROXIMAL HUMERAL PLATEAdvanced Orthopaedic Solutions, Inc.K080109SYNTHES (USA) MODULAR BLADE PLATE SYSTEMSynthes (Usa)

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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