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)

POLARUS CONNECT

K-Number: K131636 · 2013-10-10

ApplicantAcumed, LLC
Decision Date2013-10-10
Product CodeLXT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

POLARUS CONNECT is the device name listed in this FDA 510(k) record. The listed applicant is Acumed, LLC. It received FDA 510(k) clearance on 2013-10-10 under 510(k) number K131636. 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 POLARUS CONNECT?

POLARUS CONNECT is a medical device that received FDA 510(k) clearance on 2013-10-10. The listed applicant is Acumed, LLC. The 510(k) number is K131636.

When did POLARUS CONNECT receive FDA 510(k) clearance?

POLARUS CONNECT received FDA 510(k) clearance on 2013-10-10, under 510(k) number K131636.

Who is the listed applicant for POLARUS CONNECT?

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

What is the FDA product code for POLARUS CONNECT?

The FDA product code for POLARUS CONNECT 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 Acumed, 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.

K252356The Acumed Wrist Fixation System - 2.4mm ScrewsK251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsK251296The Acumed Wrist Fixation SystemK243624Acu-Sinch Knotless MiniK233311Acumed Wrist Plating SystemK230744Acumed Acutrak 3 Headless Compression Screw System

View all 30 devices →

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 BiomedicalK132704DISTAL 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)K063832SYNTHES (USA) ELBOW HINGE FIXATORSynthes (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.

↑