Cleared Traditional

HipCheck

K182359 · Stryker Corp. · Radiology
Dec 2018
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K182359 is an FDA 510(k) clearance for the HipCheck, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Stryker Corp. (San Jose, US). The FDA issued a Cleared decision on December 13, 2018, 105 days after receiving the submission on August 30, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K182359 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2018
Decision Date December 13, 2018
Days to Decision 105 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050