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510(k) K113273

SPOTLIGHT ACCESS SYSTEM by Johnson & Johnson — Product Code GZT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2012
Date Received
November 7, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor, Self-Retaining, For Neurosurgery
Device Class
Class II
Regulation Number
882.4800
Review Panel
NE
Submission Type

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  • K111571 — VIPER SYSTEMS (July 6, 2011)
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  • K103743 — CONCORDE CURVE SYSTEM (March 17, 2011)
  • K103488 — CONCORDE BULLET CAGE SYSTEM (March 2, 2011)
  • K103490 — EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM (February 17, 2011)

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  • K202072 — MindsEye Expandable Port (August 26, 2020)
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  • K172433 — NICO BrainPath (September 7, 2017)
  • K161680 — MEDICON Spinal Spreading Systems (March 24, 2017)
  • K161318 — Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological (March 20, 2017)
  • K161004 — Self-retaining Retractor (September 9, 2016)
  • K150378 — NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook (June 12, 2015)
  • K120691 — BRAIN PORT (June 5, 2012)