Cleared Special

DEPUY SYNTHES MAXFRAME AUTOSTRUT System

K231922 · DePuy Synthes · Orthopedic

Jul 2023

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K231922 is an FDA 510(k) clearance for the DEPUY SYNTHES MAXFRAME AUTOSTRUT System, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by DePuy Synthes (19380, US). The FDA issued a Cleared decision on July 26, 2023, 27 days after receiving the submission on June 29, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K231922 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 29, 2023
Decision Date	July 26, 2023
Days to Decision	27 days
Submission Type	Special
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