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)

Linkt Compression Staple System

K-Number: K250712 · 2025-05-14

ApplicantTrax Surgical
Decision Date2025-05-14
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Linkt Compression Staple System is a medical device manufactured by Trax Surgical. It received FDA 510(k) clearance on 2025-05-14 under approval number K250712. 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 Linkt Compression Staple System?

Linkt Compression Staple System is a medical device that received FDA 510(k) clearance on 2025-05-14. It is manufactured by Trax Surgical. The 510(k) number is K250712.

When was Linkt Compression Staple System approved by the FDA?

Linkt Compression Staple System received FDA 510(k) clearance on 2025-05-14, under approval number K250712.

What company makes Linkt Compression Staple System?

Linkt Compression Staple System is manufactured by Trax Surgical.

What is the FDA product code for Linkt Compression Staple System?

The FDA product code for Linkt Compression Staple System is JDR.

Related Clinical Trials

NCT07609511 Magnet System Gastric Outlet Obstruction Study NOT_YET_RECRUITING NCT07603531 Assessment of the Efficacy of the Dynamic Decongestive System in the Maintenance Phase of Lower Limb Lymphedema NOT_YET_RECRUITING NCT07600489 A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers NOT_YET_RECRUITING NCT07317076 GT Metabolic Magnet System in Adults With Gastrointestinal Disorders RECRUITING NCT07431723 Creation of Compression Anastomosis Using the GT Metabolic Magnet System RECRUITING NCT07540312 A Prospective Trial of a Variable Compression System for Moderate to Severe Irritable Bowel Syndrome RECRUITING

Other Devices by Trax Surgical

K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L

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.

↑