Cleared Traditional

Response Ortho Metaphyseal Hinge Fixator System

K241769 · Response Ortho Solutions, LLC · Orthopedic

Sep 2024

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K241769 is an FDA 510(k) clearance for the Response Ortho Metaphyseal Hinge Fixator System, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by Response Ortho Solutions, LLC (Boynton Beach, US). The FDA issued a Cleared decision on September 18, 2024, 90 days after receiving the submission on June 20, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K241769 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2024
Decision Date	September 18, 2024
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KTT — Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3030