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510(k) K161680

MEDICON Spinal Spreading Systems by Medicon EG — Product Code GZT

K161680 is an FDA 510(k) premarket notification submitted by Medicon EG for the device "MEDICON Spinal Spreading Systems". The FDA issued a decision of Substantially Equivalent on March 24, 2017. The device falls under product code GZT (Retractor, Self-Retaining, For Neurosurgery), a Class II device regulated under 21 CFR 882.4800. Medicon EG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2017
Date Received
June 17, 2016
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 Medicon EG

  • K100916 — MEDICON MOGEN CLAMP (December 6, 2010)
  • K083803 — FIXIT HEADREST CLAMP SYSTEM (March 10, 2010)
  • K053624 — MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM (July 17, 2006)
  • K050478 — MEDICON IMF-ORION SCREWS (June 15, 2005)
  • K043297 — MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM (February 23, 2005)
  • K042974 — MEDICON VIPAIR HIGH SPEED SYSTEM (January 13, 2005)
  • K041527 — AARHUS ANCHORAGE SYSTEM (August 19, 2004)
  • K010908 — MEDICON TITANIUM YASARGIL ANEURYSM CLIPS (August 1, 2001)
  • K010910 — MEDICON YASARGIL CLIP APPLYING FORCEPS (August 1, 2001)
  • K972857 — SERVOTRONIC EC100 SYSTEM (January 16, 1998)

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)
  • 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)
  • K113273 — SPOTLIGHT ACCESS SYSTEM (January 27, 2012)

FDA data resources