Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HALM ZIELKE INSTRUMENTATION SYSTEM

K-Number: K024125 · 2003-09-22

ApplicantMicomed Ortho GmbH
Decision Date2003-09-22
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HALM ZIELKE INSTRUMENTATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Micomed Ortho GmbH. It received FDA 510(k) clearance on 2003-09-22 under 510(k) number K024125. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HALM ZIELKE INSTRUMENTATION SYSTEM?

HALM ZIELKE INSTRUMENTATION SYSTEM is a medical device that received FDA 510(k) clearance on 2003-09-22. The listed applicant is Micomed Ortho GmbH. The 510(k) number is K024125.

When did HALM ZIELKE INSTRUMENTATION SYSTEM receive FDA 510(k) clearance?

HALM ZIELKE INSTRUMENTATION SYSTEM received FDA 510(k) clearance on 2003-09-22, under 510(k) number K024125.

Who is the listed applicant for HALM ZIELKE INSTRUMENTATION SYSTEM?

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

What is the FDA product code for HALM ZIELKE INSTRUMENTATION SYSTEM?

The FDA product code for HALM ZIELKE INSTRUMENTATION SYSTEM is KWQ.

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 Micomed Ortho GmbH 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.

K021275MICOMED POSTERIOR DOUBLEROD SYSTEM

Related Devices (Code: KWQ)

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.

K262149corra® cervical plating systemCarlsmed, Inc.K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC

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.

↑