Cleared Special

MAYFIELD MR/X-RAY SKULL CLAMP

K081401 · Integra Lifesciences Corp. · Neurology
Oct 2008
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K081401 is an FDA 510(k) clearance for the MAYFIELD MR/X-RAY SKULL CLAMP, a Holder, Head, Neurosurgical (skull Clamp) (Class II — Special Controls, product code HBL), submitted by Integra Lifesciences Corp. (Planisboro, US). The FDA issued a Cleared decision on October 8, 2008, 142 days after receiving the submission on May 19, 2008. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4460.

Submission Details

510(k) Number K081401 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 2008
Decision Date October 08, 2008
Days to Decision 142 days
Submission Type Special
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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