Home / 510(k) Clearances / K123723

510(k) K123723

SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM by Synthes — Product Code GWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2013
Date Received
December 4, 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 Synthes

  • K254093 — DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System (March 10, 2026)
  • K260069 — DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (March 9, 2026)
  • K254054 — VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (March 2, 2026)
  • K243715 — Synthes Patient Specific Implants (November 12, 2025)
  • K241927 — Synthes Graphic Case & Tray System (March 28, 2025)
  • K233994 — VOLT™ Proximal Humerus 3.5 Plating System (July 26, 2024)
  • K233967 — DePuy Synthes MatrixSTERNUM Fixation System (May 9, 2024)
  • K131792 — SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY (December 16, 2013)
  • K122455 — SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM (April 11, 2013)
  • K122647 — SYNTHES PATIENT SPECIFIC PLATE (February 28, 2013)

Other clearances for product code GWO

  • K250297 — TECHFIT Patient-Specific Cranial System (October 27, 2025)
  • K250334 — Fusion Craniofacial Implant; Fusion Skull Implant (July 25, 2025)
  • K231834 — VSP PEEK Cranial Implant (April 4, 2024)
  • 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)