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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device holder, head, neurosurgical (skull clamp)
Regulation Description Neurosurgical head holder (skull clamp).
Product CodeHBL
Regulation Number 882.4460
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 5
INTEGRA
  SUBSTANTIALLY EQUIVALENT 9
MEDICON, E.G.
  SUBSTANTIALLY EQUIVALENT 1
MIZUHO
  SUBSTANTIALLY EQUIVALENT 1
Ohio Medical Corporation
  SUBSTANTIALLY EQUIVALENT 7
PRO-MED INSTRUMENTS GMBH
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR TECHNOLOGY INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 6
Failure to Adhere or Bond 2
Bent 2
Crack 2
Unintended head motion 2
Difficult to position 2
Loose 1
Migration of device or device component 1
Detachment of device component 1
Defective item 1
Device operates differently than expected 1
Total Device Problems 21

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corporation II Dec-19-2012

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