Cleared Traditional

K063489 - STRYKER INTRADISCAL RF GENERATOR
(FDA 510(k) Clearance)

K063489 · Synergetics, Inc. · Neurology
May 2007
Decision
187d
Days
Class 2
Risk

K063489 is an FDA 510(k) clearance for the STRYKER INTRADISCAL RF GENERATOR, a Generator, Lesion, Radiofrequency (Class II — Special Controls, product code GXD), submitted by Synergetics, Inc. (Valley Forge, US). The FDA issued a Cleared decision on May 23, 2007, 187 days after receiving the submission on November 17, 2006. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4400.

Submission Details

510(k) Number K063489 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 2006
Decision Date May 23, 2007
Days to Decision 187 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXD — Generator, Lesion, Radiofrequency
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4400

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