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

FDA 510(k)

Precifit Medical Kirschner Wires

K-Number: K163327 · 2017-05-08

ApplicantPrecifit Medical, Ltd.
Decision Date2017-05-08
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Precifit Medical Kirschner Wires is a medical device manufactured by Precifit Medical, Ltd.. It received FDA 510(k) clearance on 2017-05-08 under approval number K163327. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Precifit Medical Kirschner Wires?

Precifit Medical Kirschner Wires is a medical device that received FDA 510(k) clearance on 2017-05-08. It is manufactured by Precifit Medical, Ltd.. The 510(k) number is K163327.

When was Precifit Medical Kirschner Wires approved by the FDA?

Precifit Medical Kirschner Wires received FDA 510(k) clearance on 2017-05-08, under approval number K163327.

What company makes Precifit Medical Kirschner Wires?

Precifit Medical Kirschner Wires is manufactured by Precifit Medical, Ltd..

What is the FDA product code for Precifit Medical Kirschner Wires?

The FDA product code for Precifit Medical Kirschner Wires is HTY.

Related Clinical Trials

NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT02911103 Deep Brain Stimulation Surgery for Focal Hand Dystonia ACTIVE_NOT_RECRUITING NCT02119611 Deep Brain Stimulation Therapy in Movement Disorders RECRUITING

Other Devices by Precifit Medical, Ltd.

K171630LumFuse-TP K173189Lumfuse TP K172568Cervage

Related Devices (Code: HTY)

K161489Syntorr K-wire and Pin SystemSyntorr, Inc. K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC K160194StarFuse Interphalangeal PinPhalanx Innovations K152662S-WireSpinal Resources, Inc. K153204In2Bones Kirschner wireIn2bones Sas K152627IFS Fixation Scaffold SystemMetric Medical Devices, 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.

↑