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)

Extremity All Suture System

K-Number: K241695 · 2024-09-12

ApplicantField Orthopaedics
Decision Date2024-09-12
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Extremity All Suture System is a medical device manufactured by Field Orthopaedics. It received FDA 510(k) clearance on 2024-09-12 under approval number K241695. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Extremity All Suture System?

Extremity All Suture System is a medical device that received FDA 510(k) clearance on 2024-09-12. It is manufactured by Field Orthopaedics. The 510(k) number is K241695.

When was Extremity All Suture System approved by the FDA?

Extremity All Suture System received FDA 510(k) clearance on 2024-09-12, under approval number K241695.

What company makes Extremity All Suture System?

Extremity All Suture System is manufactured by Field Orthopaedics.

What is the FDA product code for Extremity All Suture System?

The FDA product code for Extremity All Suture System is MBI.

Related Clinical Trials

NCT07276815 OverStitch NXT Endoscopic Suture System NOT_YET_RECRUITING NCT06087445 A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia COMPLETED NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT07603258 Access-H20: Sensor-driven Smart Faucet Related Study COMPLETED NCT06747117 A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II) RECRUITING NCT05505513 Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Feedback? RECRUITING

Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

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.

↑