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510(k) K122049

NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM by Kinamed, Inc. — Product Code GWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2013
Date Received
July 12, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Cranioplasty, Preformed, Alterable
Device Class
Class II
Regulation Number
882.5320
Review Panel
NE
Submission Type

Other clearances by Kinamed, Inc.

  • K072250 — SUPERCABLE GRIP AND PLATE SYSTEM (November 9, 2007)
  • K050897 — NAVIPRO SHOULDER SOFTWARE MODULE (May 24, 2005)
  • K033668 — NAVIPRO KNEE SOFTWARE MODULE (March 11, 2004)
  • K032950 — GEM INSET PATELLAR COMPONENT (December 19, 2003)
  • K030256 — ISO-ELASTIC CERCLAGE SYSTEM (October 21, 2003)
  • K020764 — NAVIPRO (June 3, 2002)
  • K013982 — KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT (May 21, 2002)
  • K010101 — GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM (May 17, 2001)
  • K003347 — ORTHOPILOT (February 23, 2001)
  • K994214 — GEM KNEE SYSTEM (July 19, 2000)

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  • K212391 — MCI-Neuro Fixation System (October 21, 2022)
  • K210360 — Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neu (January 27, 2022)
  • K203055 — Stryker PEEK Customized Cranial Implant Kit (February 9, 2021)
  • K190811 — Optimus NEURO System - Sterile Kit (November 27, 2019)
  • K190229 — Stryker PEEK Customized Cranial Implant Kit (July 11, 2019)
  • K182711 — Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) (May 21, 2019)
  • K183352 — Optimus Neuro System (January 2, 2019)