Cleared Traditional

K050319 - MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104
(FDA 510(k) Clearance)

K050319 · Integra Lifesciences Corp. · Neurology
Mar 2005
Decision
50d
Days
Class 2
Risk

K050319 is an FDA 510(k) clearance for the MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104, a Holder, Head, Neurosurgical (skull Clamp) (Class II — Special Controls, product code HBL), submitted by Integra Lifesciences Corp. (Cincinnati, US). The FDA issued a Cleared decision on March 31, 2005, 50 days after receiving the submission on February 9, 2005. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4460.

Submission Details

510(k) Number K050319 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 2005
Decision Date March 31, 2005
Days to Decision 50 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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