Plate, Cranioplasty, Preformed, Alterable

FDA product code GWO · 38 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.5320
Review panel: NE
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1981-11-06 – 2026-09-11

GWO 2026-09-11

CraniUS Plate

Applicant CraniUS, LLC

K number K262874

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GWO 2026-07-29

CraniUS Plate

Applicant CraniUS, LLC

K number K261058

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GWO 2025-10-27

TECHFIT Patient-Specific Cranial System

Applicant Techfit Digital Surgery, Inc.

K number K250297

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GWO 2025-07-25

Fusion Craniofacial Implant; Fusion Skull Implant

Applicant Kelyniam Global, Inc.

K number K250334

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GWO 2024-04-04

VSP PEEK Cranial Implant

Applicant 3D Systems, Inc.

K number K231834

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GWO 2022-10-21

MCI-Neuro Fixation System

Applicant Mci Medical Concept Innovation, Inc.

K number K212391

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GWO 2022-01-27

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)

Applicant Osteonic Co., Ltd.

K number K210360

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GWO 2021-02-09

Stryker PEEK Customized Cranial Implant Kit

Applicant Stryker

K number K203055

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GWO 2019-11-27

Optimus NEURO System - Sterile Kit

Applicant Osteonic Co., Ltd.

K number K190811

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GWO 2019-07-11

Stryker PEEK Customized Cranial Implant Kit

Applicant Stryker

K number K190229

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GWO 2019-05-21

Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)

Applicant Kelyniam Global, Inc.

K number K182711

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GWO 2019-01-02

Optimus Neuro System

Applicant Osteonic Co., Ltd.

K number K183352

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GWO 2018-11-06

Universal Mesh - Sterile

Applicant Stryker Leibinger GmbH & Co KG

K number K182425

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GWO 2017-11-13

Stryker Universal Mesh

Applicant Stryker

K number K170725

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GWO 2017-09-11

Sterile NS System

Applicant Jeil Medical Corporation

K number K170368

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GWO 2016-12-08

Stryker Universal Mesh

Applicant Stryker

K number K161821

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GWO 2016-09-27

Biopor Porous Polyethylene Implants

Applicant Ceremed , Inc.

K number K161446

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GWO 2016-03-10

PEEK Customized Cranial Implant

Applicant Stryker

K number K153248

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GWO 2013-10-17

UNIVERSAL NEURO 3 SYSTEM

Applicant Stryker

K number K131775

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GWO 2013-09-05

SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM

Applicant Synthes

K number K123723

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GWO 2013-04-05

NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM

Applicant Kinamed, Inc.

K number K122049

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GWO 2013-01-17

RESORB-X G

Applicant KLS-Martin L.P.

K number K121606

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GWO 2012-10-12

BIOMET MICROFIXATION NEURO PLATING SYSTEM

Applicant Biomet Microfixation

K number K121624

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GWO 2012-09-14

PEEK CUSTOMIZED CRAIAL IMPLANT KIT

Applicant Stryker

K number K121153

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GWO 2012-06-11

STRYKER QUIKFLAP STERILE PROCEDURE PACK

Applicant Stryker

K number K120352

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GWO 2012-02-22

LEFORTE NEURO SYSTEM BONE PLATE

Applicant Jeil Medical Corporation

K number K112812

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GWO 2012-01-05

STRYKER UNIVERSAL NEURO 3 SYSTEM

Applicant Stryker

K number K112557

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GWO 2011-08-15

OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM

Applicant Osteomed LP

K number K111176

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GWO 2011-07-14

STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT

Applicant Howmedica Osteonics Corp. Dba Stryker Orthopeadics

K number K111065

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GWO 2010-12-13

FRONTIER DEVICES NEURO SYSTEM

Applicant Folsom Metal Products, Inc.

K number K100205

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GWO 2008-05-29

OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM

Applicant Takiron Co., Ltd.

K number K073006

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GWO 2007-12-18

SYNTHES (USA) 2.0MM TITANIUM T-PLATE

Applicant Synthes (Usa)

K number K072758

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GWO 1998-03-16

SYNTHES CRANIAL SPRING CLIP (CSC)

Applicant Synthes (Usa)

K number K974206

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GWO 1991-02-21

TITANIUM MESH

Applicant Ruggles Corp.

K number K903485

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GWO 1986-10-14

NEUROSCOPE SEEG

Applicant Siegen Corp.

K number K861884

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GWO 1986-07-11

MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI

Applicant Valley Forge Scientific Corp.

K number K861822

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GWO 1981-11-06

RION AUDIOMETER AA-68

Applicant Rion Acoustic Instruments, Inc.

K number K812952

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GWO 1981-11-06

RION AUDIOMETER AA-67

Applicant Rion Acoustic Instruments, Inc.

K number K812951

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