Cleared Traditional

Hoffmann LRF System

K203568 · Stryker GmbH · Orthopedic

Feb 2021

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K203568 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 (Malwah, US). The FDA issued a Cleared decision on February 1, 2021, 56 days after receiving the submission on December 7, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K203568 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 07, 2020
Decision Date	February 01, 2021
Days to Decision	56 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