Home / 510(k) Clearances / K062814

510(k) K062814

PIPELINE II ACCESS SYSTEM by Depuy Spine, Inc. — Product Code GZT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2006
Date Received
September 20, 2006
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

Other clearances by Depuy Spine, Inc.

  • K222276 — CONDUIT Cages; FIBERGRAFT BG Putty (October 15, 2022)
  • K201831 — CONFIDENCE Spinal Cement System (August 31, 2020)
  • K142185 — EXPEDIUM VERSE SPINE SYSTEM (November 19, 2014)
  • K111136 — EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM (June 14, 2012)
  • K121020 — VIPER SYSTEM (May 3, 2012)
  • K110353 — MOUNTAINEER OCT SPINAL SYSTEM (April 7, 2011)
  • K110216 — EXPEDIUM SYSTEM, VIPER SYSTEM (April 1, 2011)
  • K103133 — VEPER SYSTEM, EXPEDIUM SYSTEM (January 18, 2011)
  • K101993 — VIPER SYSTEM, EXPEDIUM SYSTEM (December 7, 2010)
  • K101923 — CONCORDE CURVE SYSTEM (December 1, 2010)

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)