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FDA 510(k)

WRIST FUSION PLATE

K-Number: K052754 · 2005-10-27

ApplicantDvo Extremity Solutions, LLC
Decision Date2005-10-27
Product CodeLXT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

WRIST FUSION PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Dvo Extremity Solutions, LLC. It received FDA 510(k) clearance on 2005-10-27 under 510(k) number K052754. The device is classified under product code LXT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WRIST FUSION PLATE?

WRIST FUSION PLATE is a medical device that received FDA 510(k) clearance on 2005-10-27. The listed applicant is Dvo Extremity Solutions, LLC. The 510(k) number is K052754.

When did WRIST FUSION PLATE receive FDA 510(k) clearance?

WRIST FUSION PLATE received FDA 510(k) clearance on 2005-10-27, under 510(k) number K052754.

Who is the listed applicant for WRIST FUSION PLATE?

The FDA 510(k) record lists Dvo Extremity Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WRIST FUSION PLATE?

The FDA product code for WRIST FUSION PLATE is LXT.

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 Dvo Extremity Solutions, LLC 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.

K073331DVO EXTENDED ARTICULATION HUMERAL HEADSK060988TOTAL AND HEMI SHOULDER SYSTEMK052150VOLAR PLATE SYSTEM

Related Devices (Code: LXT)

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.

K230067Para-Fix External Fixation SystemNew Paradigm BiomedicalK131636POLARUS CONNECTAcumed, LLCK132704DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROWBiometK112345DISTAL VOLAR RADIUS PLATING SYSTEMSMedos International SARLK090374STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(SDePuy Orthopaedics, Inc.K073135SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONSSynthes (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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