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510(k) K112913

SPOTLIGHT ACCESS SYSTEM by Johnson & Johnson — Product Code GZT

K112913 is an FDA 510(k) premarket notification submitted by Johnson & Johnson for the device "SPOTLIGHT ACCESS SYSTEM". The FDA issued a decision of Substantially Equivalent on December 16, 2011. The device falls under product code GZT (Retractor, Self-Retaining, For Neurosurgery), a Class II device regulated under 21 CFR 882.4800. Johnson & Johnson has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2011
Date Received
October 3, 2011
Clearance Type
Special
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

Other clearances by Johnson & Johnson

  • K142460 — EXPEDIUM Spine System/Synapse System (October 1, 2014)
  • K113273 — SPOTLIGHT ACCESS SYSTEM (January 27, 2012)
  • K113348 — COUGAR SYSTEM (December 13, 2011)
  • K110551 — EXPEDIUM SPINE SYSTEM (October 26, 2011)
  • K110694 — CONCORDE BULLET SPINAL SYSTEM (October 11, 2011)
  • K111571 — VIPER SYSTEMS (July 6, 2011)
  • K110454 — COUGAR LS LATERAL CAGE SYSTEM (May 13, 2011)
  • 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)

Other clearances for product code GZT

  • K210615 — Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clam (May 13, 2022)
  • K202694 — Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (January 14, 2021)
  • K202072 — MindsEye Expandable Port (August 26, 2020)
  • K180610 — Geister retractor for neuro - and spine surgery (August 29, 2018)
  • 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)

FDA data resources