Cleared Special

Hoffmann LRF System

K233741 · Stryker GmbH · Orthopedic

Dec 2023

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K233741 is an FDA 510(k) clearance for the Hoffmann LRF System, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by Stryker GmbH (Selzach, CH). The FDA issued a Cleared decision on December 21, 2023, 29 days after receiving the submission on November 22, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K233741 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 22, 2023
Decision Date	December 21, 2023
Days to Decision	29 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