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510(k) K964402

VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM by V. Mueller Neuro/Spine — Product Code GZT

K964402 is an FDA 510(k) premarket notification submitted by V. Mueller Neuro/Spine for the device "VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM". The FDA issued a decision of Substantially Equivalent on January 23, 1997. The device falls under product code GZT (Retractor, Self-Retaining, For Neurosurgery), a Class II device regulated under 21 CFR 882.4800. V. Mueller Neuro/Spine has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1997
Date Received
November 4, 1996
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 V. Mueller Neuro/Spine

  • K002276 — PSI SKULL CLAMP (August 29, 2000)
  • K993019 — PACIFIC SURGICAL PATTIES (March 30, 2000)
  • K991959 — PSI TITANIUM ANEURYSM CLIP (January 6, 2000)
  • K991002 — PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP (June 11, 1999)
  • K972750 — TAKA ANEURYSM CLIP (July 9, 1998)
  • K942601 — PSI FLEXIBLE ARM (December 27, 1994)
  • K943635 — ULTRA-LINE RONGEUR (December 7, 1994)

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