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)

NITINEX Memory Compression Staple

K-Number: K231493 · 2023-08-11

ApplicantVilex, LLC
Decision Date2023-08-11
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NITINEX Memory Compression Staple is a medical device manufactured by Vilex, LLC. It received FDA 510(k) clearance on 2023-08-11 under approval number K231493. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NITINEX Memory Compression Staple?

NITINEX Memory Compression Staple is a medical device that received FDA 510(k) clearance on 2023-08-11. It is manufactured by Vilex, LLC. The 510(k) number is K231493.

When was NITINEX Memory Compression Staple approved by the FDA?

NITINEX Memory Compression Staple received FDA 510(k) clearance on 2023-08-11, under approval number K231493.

What company makes NITINEX Memory Compression Staple?

NITINEX Memory Compression Staple is manufactured by Vilex, LLC.

What is the FDA product code for NITINEX Memory Compression Staple?

The FDA product code for NITINEX Memory Compression Staple is JDR.

Related Clinical Trials

NCT05477719 Effect of Compression Stockings on the Number of Apneas/Hypopneas Per Hour of Sleep in Patients With Syndrome Obstructive Sleep Apnea/Hypopnea as Compared to no Treatment COMPLETED

Other Devices by Vilex, LLC

K202143Dynex Micro K202054Dynex Ring Fixation System, Diametrix Ring Fixation System K212552Correx Software K221342REDEMPTION Beaming System K221558ALPHALOK Plating System K212348ALPHALOK™ Plating System

View all 17 devices →

Related Devices (Code: JDR)

K161426NeoSpan Compression Staple Impant w/instrumentsIn2bones USA, LLC K160813EasyStepStryker GmbH K153622First Ray Internal Bone Staple SystemFirst Ray, LLC K153770OS2(R)-VP Varisation StapleIn2bones Sas K153395OS2-C Compression StapleIn2bones Sas K153129dynaMX Tabbed StapleMx Orthopedics, Corp.

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.

↑