Cleared Traditional

OASYS System

K150753 · Stryker Corporation · Orthopedic
Jun 2015
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K150753 is an FDA 510(k) clearance for the OASYS System, a Appliance, Fixation, Spinal Interlaminal (Class II — Special Controls, product code KWP), submitted by Stryker Corporation (Allendale, US). The FDA issued a Cleared decision on June 9, 2015, 78 days after receiving the submission on March 23, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K150753 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2015
Decision Date June 09, 2015
Days to Decision 78 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWP — Appliance, Fixation, Spinal Interlaminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3050

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