Cleared Special

RAPIDFIRE SELF DRILLING SCREWS

K031751 · Walter Lorenz Surgical, Inc. · Orthopedic
Jun 2003
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K031751 is an FDA 510(k) clearance for the RAPIDFIRE SELF DRILLING SCREWS, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on June 26, 2003, 21 days after receiving the submission on June 5, 2003. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K031751 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 2003
Decision Date June 26, 2003
Days to Decision 21 days
Submission Type Special
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