TECHFIT DISRP® System— 510(k) K242263

Name: FDA 510(k) clearance K242263
Creator: U.S. Food and Drug Administration
Published: 2024-12-11

Substantially Equivalent

Techfit Digital Surgery, Inc.

FDA 510(k) clearance K242263 for TECHFIT DISRP® System, Substantially Equivalent on 2024-12-11. Applicant: Techfit Digital Surgery, Inc.. Device class: 2.

Clearance details

Applicant: Techfit Digital Surgery, Inc.
Product code: Code DZJ
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2024-08-01
Decision date: 2024-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daytona Beach, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZJ

view all

K261826 — VSP System (Titanium Palatal Splint)2026-06-03
K243637 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery2025-02-21
K231520 — tmCMF Solution2023-10-02
K230276 — TECHFIT DISRP® System2023-06-23
K223024 — MedCAD AccuPlan System2023-03-07

More clearances from Techfit Digital Surgery, Inc.

view all

K250297 — TECHFIT Patient-Specific Cranial System2025-10-27
K222577 — TECHFIT Diagnostic Models2023-01-06
K220199 — AFFINITY Proximal Tibia System2022-03-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.