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FDA 510(k)

LERE NAIL & PLATE COMBIN. ONE PIECE FORGED

K-Number: K851349 · 1985-05-29

ApplicantMedicalex
Decision Date1985-05-29
Product CodeKTW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LERE NAIL & PLATE COMBIN. ONE PIECE FORGED is the device name listed in this FDA 510(k) record. The listed applicant is Medicalex. It received FDA 510(k) clearance on 1985-05-29 under 510(k) number K851349. 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 LERE NAIL & PLATE COMBIN. ONE PIECE FORGED?

LERE NAIL & PLATE COMBIN. ONE PIECE FORGED is a medical device that received FDA 510(k) clearance on 1985-05-29. The listed applicant is Medicalex. The 510(k) number is K851349.

When did LERE NAIL & PLATE COMBIN. ONE PIECE FORGED receive FDA 510(k) clearance?

LERE NAIL & PLATE COMBIN. ONE PIECE FORGED received FDA 510(k) clearance on 1985-05-29, under 510(k) number K851349.

Who is the listed applicant for LERE NAIL & PLATE COMBIN. ONE PIECE FORGED?

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

What is the FDA product code for LERE NAIL & PLATE COMBIN. ONE PIECE FORGED?

The FDA product code for LERE NAIL & PLATE COMBIN. ONE PIECE FORGED is KTW.

Related Clinical Trials

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 Medicalex 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.

K850946SURGICAL ASPIRATORK833377MEDICALEXK831728MEDICALEX

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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