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)

APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension

K-Number: K232251 · 2023-11-03

ApplicantMedartis AG
Decision Date2023-11-03
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension is a medical device manufactured by Medartis AG. It received FDA 510(k) clearance on 2023-11-03 under approval number K232251. 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 APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension?

APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension is a medical device that received FDA 510(k) clearance on 2023-11-03. It is manufactured by Medartis AG. The 510(k) number is K232251.

When was APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension approved by the FDA?

APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension received FDA 510(k) clearance on 2023-11-03, under approval number K232251.

What company makes APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension?

APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension is manufactured by Medartis AG.

What is the FDA product code for APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension?

The FDA product code for APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension is HWC. This falls under the Cardiovascular category.

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 NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING

Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024)

Other Devices by Medartis AG

K172170APTUS(R) Wrist 2.5 System K161861APTUS® Coronoid 2.0 K181009APTUS CMC-I Fusion Plate System K181425APTUS® Proximal Humerus System K192297APTUS Wrist Arthrodesis Plates K191848APTUS Wrist Spanning Plates 2.5

View all 22 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.

↑