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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orthopedic stereotaxic instrument
Regulation Description Stereotaxic instrument.
Definition Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
Product CodeOLO
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 8
MAKO SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 5
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 6
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Mako Surgical Corporation II Nov-19-2012
2 Mako Surgical Corporation II Nov-01-2011
3 Smith & Nephew Inc II Nov-18-2010

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