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)

POGO SCREW INSTRUMENTATION TRAY

K-Number: K091806 · 2010-02-22

ApplicantFxdevices
Decision Date2010-02-22
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POGO SCREW INSTRUMENTATION TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Fxdevices. It received FDA 510(k) clearance on 2010-02-22 under 510(k) number K091806. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POGO SCREW INSTRUMENTATION TRAY?

POGO SCREW INSTRUMENTATION TRAY is a medical device that received FDA 510(k) clearance on 2010-02-22. The listed applicant is Fxdevices. The 510(k) number is K091806.

When did POGO SCREW INSTRUMENTATION TRAY receive FDA 510(k) clearance?

POGO SCREW INSTRUMENTATION TRAY received FDA 510(k) clearance on 2010-02-22, under 510(k) number K091806.

Who is the listed applicant for POGO SCREW INSTRUMENTATION TRAY?

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

What is the FDA product code for POGO SCREW INSTRUMENTATION TRAY?

The FDA product code for POGO SCREW INSTRUMENTATION TRAY is KCT.

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 Fxdevices 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.

K092189POGO SCREWK080649POGO SCREWK070393LAGWIRE SYSTEM

Related Devices (Code: KCT)

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.

K253988LiteSet TraysNobel Biocare ABK261935Surgical and Prosthetic TraysDentsply Sirona, Inc.K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, 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.

↑