Product code GWO— Neurology
CraniUS Plate
- Classification name
- Plate, Cranioplasty, Preformed, Alterable
- Device class
- Class 2
- Regulation
- 21 CFR 882.5320
- Advisory panel
- Neurology
- Total cleared
- 44
- First cleared
- Most recent
Market context for product code GWO
FDA has cleared devices under product code GWO between 1981 and 2026, filed by 26 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2022
- 2021
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
Top applicants under product code GWO
Adverse events under product code GWO
product code GWO- Malfunction
- 583
- Total
- 583
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code GWO
- K262874 — CraniUS Plate
- K261058 — CraniUS Plate
- K250297 — TECHFIT Patient-Specific Cranial System
- K250334 — Fusion Craniofacial Implant; Fusion Skull Implant
- K231834 — VSP PEEK Cranial Implant
- K212391 — MCI-Neuro Fixation System
- K210360 — Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)
- K203055 — Stryker PEEK Customized Cranial Implant Kit
- K190811 — Optimus NEURO System - Sterile Kit
- K190229 — Stryker PEEK Customized Cranial Implant Kit
- K182711 — Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)
- K183352 — Optimus Neuro System
- K182425 — Universal Mesh - Sterile
- K170725 — Stryker Universal Mesh
- K170368 — Sterile NS System
- K161821 — Stryker Universal Mesh
- K161446 — Biopor Porous Polyethylene Implants
- K153248 — PEEK Customized Cranial Implant
- K152076 — PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority
- K141123 — ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM
- K141911 — OPTIMUS NEURO SYSTEM
- K141644 — INNOVASIS CRANIAL SYSTEM
- K141452 — LEFORTE NEURO SYSTEM BONE PLATE AND SCREW
- K140462 — MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)
- K131775 — UNIVERSAL NEURO 3 SYSTEM
- K123723 — SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM
- K122049 — NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM
- K121606 — RESORB-X G
- K121624 — BIOMET MICROFIXATION NEURO PLATING SYSTEM
- K121153 — PEEK CUSTOMIZED CRAIAL IMPLANT KIT
- K120352 — STRYKER QUIKFLAP STERILE PROCEDURE PACK
- K112812 — LEFORTE NEURO SYSTEM BONE PLATE
- K112557 — STRYKER UNIVERSAL NEURO 3 SYSTEM
- K111176 — OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM
- K111065 — STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT
- K100205 — FRONTIER DEVICES NEURO SYSTEM
- K073006 — OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM
- K072758 — SYNTHES (USA) 2.0MM TITANIUM T-PLATE
- K974206 — SYNTHES CRANIAL SPRING CLIP (CSC)
- K903485 — TITANIUM MESH
- K861884 — NEUROSCOPE SEEG
- K861822 — MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI
- K812951 — RION AUDIOMETER AA-67
- K812952 — RION AUDIOMETER AA-68
Data sourced from openFDA. This site is unofficial and independent of the FDA.