Cleared Abbreviated

Locking Screw,CoCrMo

K242348 · Double Medical Technology, Inc. · Orthopedic
Dec 2024
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K242348 is an FDA 510(k) clearance for the Locking Screw,CoCrMo, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Double Medical Technology, Inc. (Xiamen, CN). The FDA issued a Cleared decision on December 4, 2024, 118 days after receiving the submission on August 8, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K242348 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2024
Decision Date December 04, 2024
Days to Decision 118 days
Submission Type Abbreviated
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

Similar Devices — HWC Screw, Fixation, Bone

All 1049
Treace Medical Concepts (TMC) Screw Fixation System
K260361 · Treace Medical Concepts, Inc. · Mar 2026
Tyber Medical Trauma Screw
K252901 · Tyber Medical, LLC · Dec 2025
Ultra? Compression Screw System
K251555 · Pace Surgical · Nov 2025
Eleganz IM Threaded Nail System (IM Threaded Nail System)
K252312 · Dev4 · Oct 2025
MetaFore Small Screw System
K250536 · Extremity Medical, LLC · Oct 2025
Cannulated Screw and Kirschner (K wire) System
K252758 · Orthonovis, Inc. · Oct 2025