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)

Acumed Acutrak 3 Headless Compression Screw System

K-Number: K230744 · 2023-06-09

ApplicantAcumed, LLC
Decision Date2023-06-09
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Acumed Acutrak 3 Headless Compression Screw System is a medical device manufactured by Acumed, LLC. It received FDA 510(k) clearance on 2023-06-09 under approval number K230744. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Acumed Acutrak 3 Headless Compression Screw System?

Acumed Acutrak 3 Headless Compression Screw System is a medical device that received FDA 510(k) clearance on 2023-06-09. It is manufactured by Acumed, LLC. The 510(k) number is K230744.

When was Acumed Acutrak 3 Headless Compression Screw System approved by the FDA?

Acumed Acutrak 3 Headless Compression Screw System received FDA 510(k) clearance on 2023-06-09, under approval number K230744.

What company makes Acumed Acutrak 3 Headless Compression Screw System?

Acumed Acutrak 3 Headless Compression Screw System is manufactured by Acumed, LLC.

What is the FDA product code for Acumed Acutrak 3 Headless Compression Screw System?

The FDA product code for Acumed Acutrak 3 Headless Compression Screw System is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING 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

Other Devices by Acumed, LLC

K210750Acumed Clavicle Hook Plating System K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional K212990Acumed Ankle Syndesmosis Repair System K233311Acumed Wrist Plating System K252356The Acumed Wrist Fixation System - 2.4mm Screws K251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws

View all 9 devices →

Related Devices (Code: HWC)

K161259KLS Martin Cannulated Headless ScrewsKLS Martin L.P. K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek K161597Tyber Medical BioTy® Nanotopography Trauma ScrewTyber Medical, LLC K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc. K161449HammerTech Fixation SystemFusion Orthopedics, LLC

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.

↑