Product code GWO
- Device name
- Plate, Cranioplasty, Preformed, Alterable
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.5320
- Review panel
- NE
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250297 | TECHFIT Patient-Specific Cranial System | Techfit Digital Surgery, Inc. | 2025-10-27 |
| K250334 | Fusion Craniofacial Implant; Fusion Skull Implant | Kelyniam Global, Inc. | 2025-07-25 |
| K231834 | VSP PEEK Cranial Implant | 3D Systems, Inc. | 2024-04-04 |
| K212391 | MCI-Neuro Fixation System | Mci Medical Concept Innovation, Inc. | 2022-10-21 |
| 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 m... | Osteonic Co., Ltd. | 2022-01-27 |
| K203055 | Stryker PEEK Customized Cranial Implant Kit | Stryker | 2021-02-09 |
| K190811 | Optimus NEURO System - Sterile Kit | Osteonic Co., Ltd. | 2019-11-27 |
| K190229 | Stryker PEEK Customized Cranial Implant Kit | Stryker | 2019-07-11 |
| K182711 | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) | Kelyniam Global, Inc. | 2019-05-21 |
| K183352 | Optimus Neuro System | Osteonic Co., Ltd. | 2019-01-02 |
| K182425 | Universal Mesh - Sterile | Stryker Leibinger GmbH & Co KG | 2018-11-06 |
| K170725 | Stryker Universal Mesh | Stryker | 2017-11-13 |
| K170368 | Sterile NS System | Jeil Medical Corporation | 2017-09-11 |
| K161821 | Stryker Universal Mesh | Stryker | 2016-12-08 |
| K161446 | Biopor Porous Polyethylene Implants | Ceremed , Inc. | 2016-09-27 |
| K153248 | PEEK Customized Cranial Implant | Stryker | 2016-03-10 |
| K152076 | PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority | Stryker | 2015-08-26 |
| K141123 | ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM | Alliance Partners, LLC | 2015-02-27 |
| K141911 | OPTIMUS NEURO SYSTEM | Osteonic Co., Ltd. | 2015-02-10 |
| K141644 | INNOVASIS CRANIAL SYSTEM | Innovasis, Inc. | 2014-11-07 |
| K141452 | LEFORTE NEURO SYSTEM BONE PLATE AND SCREW | Jeil Medical Corporation | 2014-07-02 |
| K140462 | MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM) | Synthes (USA) Products, LLC | 2014-06-13 |
| K131775 | UNIVERSAL NEURO 3 SYSTEM | Stryker | 2013-10-17 |
| K123723 | SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM | Synthes | 2013-09-05 |
| K122049 | NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM | Kinamed, Inc. | 2013-04-05 |
| K121606 | RESORB-X G | KLS-Martin L.P. | 2013-01-17 |
| K121624 | BIOMET MICROFIXATION NEURO PLATING SYSTEM | Biomet Microfixation | 2012-10-12 |
| K121153 | PEEK CUSTOMIZED CRAIAL IMPLANT KIT | Stryker | 2012-09-14 |
| K120352 | STRYKER QUIKFLAP STERILE PROCEDURE PACK | Stryker | 2012-06-11 |
| K112812 | LEFORTE NEURO SYSTEM BONE PLATE | Jeil Medical Corporation | 2012-02-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810125929861 | CUSTOMIZED SKULL IMPLANT (CSI) | KELYNIAM GLOBAL, INC. | 2026-07-06 |
| 00810125929878 | CUSTOMIZED SKULL IMPLANT (CSI) | KELYNIAM GLOBAL, INC. | 2026-07-06 |
| 00810125929885 | CUSTOMIZED SKULL IMPLANT (CSI) | KELYNIAM GLOBAL, INC. | 2026-07-06 |
| 00810125929830 | FUSION SKULL IMPLANT | KELYNIAM GLOBAL, INC. | 2026-06-24 |
| 00810125929847 | CUSTOMIZED SKULL IMPLANT (CSI) | KELYNIAM GLOBAL, INC. | 2026-06-24 |
| 00810125929854 | CUSTOMIZED SKULL IMPLANT (CSI) | KELYNIAM GLOBAL, INC. | 2026-06-24 |
| 00810125929823 | CUSTOMIZED SKULL IMPLANT (CSI) | KELYNIAM GLOBAL, INC. | 2026-06-24 |
| 00810125929687 | CUSTOMIZED SKULL IMPLANT (CSI) | KELYNIAM GLOBAL, INC. | 2026-06-10 |
| 00810125929694 | CUSTOMIZED SKULL IMPLANT (CSI) | KELYNIAM GLOBAL, INC. | 2026-06-10 |
| 00810125929700 | CUSTOMIZED SKULL IMPLANT (CSI) | KELYNIAM GLOBAL, INC. | 2026-06-10 |
| 00810125929717 | FUSION SKULL IMPLANT | KELYNIAM GLOBAL, INC. | 2026-06-10 |
| 00810125929724 | CUSTOMIZED SKULL IMPLANT (CSI) | KELYNIAM GLOBAL, INC. | 2026-06-10 |
| 00810125929731 | CUSTOMIZED SKULL IMPLANT (CSI) | KELYNIAM GLOBAL, INC. | 2026-06-10 |
| 00810125929748 | FUSION SKULL IMPLANT | KELYNIAM GLOBAL, INC. | 2026-06-10 |
| 00810125929755 | CUSTOMIZED CRANIOFACIAL IMPLANT (CCI) | KELYNIAM GLOBAL, INC. | 2026-06-10 |
| 07613327300017 | NA | Stryker Leibinger GmbH & Co. KG | 2017-02-21 |
| 07613327129236 | NA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613327129243 | NA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613327129250 | NA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613327129267 | NA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613327129274 | NA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613327129281 | NA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613327129298 | NA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613327129328 | NA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 07613327129335 | NA | Stryker Leibinger GmbH & Co. KG | 2015-09-24 |
| 04546540730787 | NA | Stryker Leibinger GmbH & Co. KG | 2015-07-03 |
| 04546540730794 | NA | Stryker Leibinger GmbH & Co. KG | 2015-07-03 |
| 04546540730800 | NA | Stryker Leibinger GmbH & Co. KG | 2015-07-03 |
| 07613327004021 | NA | Stryker Leibinger GmbH & Co. KG | 2015-07-03 |
| 04546540730763 | NA | Stryker Leibinger GmbH & Co. KG | 2015-07-03 |