Cleared Traditional

FIXIT HEADREST CLAMP SYSTEM

K083803 · Medicon EG · Neurology
Mar 2010
Decision
443d
Days
Class 2
Risk

About This 510(k) Submission

K083803 is an FDA 510(k) clearance for the FIXIT HEADREST CLAMP SYSTEM, a Holder, Head, Neurosurgical (skull Clamp) (Class II — Special Controls, product code HBL), submitted by Medicon EG (Tuttlingen, DE). The FDA issued a Cleared decision on March 10, 2010, 443 days after receiving the submission on December 22, 2008. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4460.

Submission Details

510(k) Number K083803 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2008
Decision Date March 10, 2010
Days to Decision 443 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBL — Holder, Head, Neurosurgical (skull Clamp)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4460

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