Cleared Traditional

STRYKER KWIC NEEDLE

K140868 · Orthovita, Inc. · Neurology
Jun 2014
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K140868 is an FDA 510(k) clearance for the STRYKER KWIC NEEDLE, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Orthovita, Inc. (Malvern, US). The FDA issued a Cleared decision on June 5, 2014, 63 days after receiving the submission on April 3, 2014. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K140868 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2014
Decision Date June 05, 2014
Days to Decision 63 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HAW — Neurological Stereotaxic Instrument
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4560

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