Cleared Traditional

TECHFIT DISRP? System

K242263 · Techfit Digital Surgery, Inc. · Dental
Dec 2024
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K242263 is an FDA 510(k) clearance for the TECHFIT DISRP? System, a Driver, Wire, And Bone Drill, Manual (Class II — Special Controls, product code DZJ), submitted by Techfit Digital Surgery, Inc. (Daytona Beach, US). The FDA issued a Cleared decision on December 11, 2024, 132 days after receiving the submission on August 1, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K242263 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2024
Decision Date December 11, 2024
Days to Decision 132 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZJ — Driver, Wire, And Bone Drill, Manual
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4120