Cleared Traditional

HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM

K113327 · Stryker Corp. · Orthopedic

Mar 2012

Decision

140d

Days

Class 2

Risk

About This 510(k) Submission

K113327 is an FDA 510(k) clearance for the HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM, 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 March 29, 2012, 140 days after receiving the submission on November 10, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K113327 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 10, 2011
Decision Date	March 29, 2012
Days to Decision	140 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