Cleared Traditional

HOFFMANN 3

K122284 · Stryker Corp. · Orthopedic

Oct 2012

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K122284 is an FDA 510(k) clearance for the HOFFMANN 3, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by Stryker Corp. (Malwah, US). The FDA issued a Cleared decision on October 24, 2012, 86 days after receiving the submission on July 30, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K122284 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 30, 2012
Decision Date	October 24, 2012
Days to Decision	86 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