Mayfield Radiolucent Skull Pins, Model 4-0-A-2020

• • Terminated Z-1221-04 FDA Unclassified (pre-2012) ·initiated 29 Jun 2004

  Skull pins, which fractured below device specifications during QC testing, were distributed.

510(k) Number

K021604 ↗

FDA Product Code

HBL

Device Class

Class II

Regulation

21 CFR Part 882.4460

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Cuddle Up Pillow

  Class I

  FDA 510(k) K882544 Active Cleared 31 Jan 1989

• Mayfield Adult Disposable Skull Pin

  Class II

  FDA 510(k) K932860 Active Cleared 28 Sep 1993

• Mayfield Radiolucent Skull Clamp

  Class II

  FDA 510(k) K934289 Active Cleared 7 Jan 1994

• The Mayfield / Acciss System with Windows Nt for Cranial Surgery, the Mayfield / Optical Acciss System with Windows Nt F

  Class II

  FDA 510(k) K992843 Active Cleared 2 Nov 1999

• Mayfield Acciss Optical System

  Class II

  FDA 510(k) K982244 Active Cleared 23 Sep 1998

• Budde-Halo Retractor

  Class II

  FDA 510(k) K830332 Active Cleared 2 Mar 1983

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