GWOClass II
Plate, Cranioplasty, Preformed, Alterable
21 CFR 882.5320 / Neurology
GWO is the FDA product code for Plate, Cranioplasty, Preformed, Alterable, a class II device type, regulated under 21 CFR 882.5320. As of , FDA records hold 43 510(k) clearances under this code, the most recent dated , and 24 recalls.
Classification record
- Product code
- GWO
- Device name
- Plate, Cranioplasty, Preformed, Alterable
- Regulation
- 21 CFR 882.5320
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 44
- Ingested recalls
- 24
Clearances, product code GWO
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1981 | 2 |
| 1986 | 2 |
| 1991 | 1 |
| 1998 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 5 |
| 2013 | 4 |
| 2014 | 3 |
| 2015 | 3 |
| 2016 | 3 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 4 |
| 2021 | 1 |
| 2022 | 2 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 2 |
Applicants with the most clearances
Product code GWO| Applicant | Clearances |
|---|---|
| Stryker Corp. | 10 |
| Osteonic Co., Ltd. | 4 |
| Jeil Medical Corporation | 3 |
| Synthes (USA) Products LLC | 3 |
| Kelyniam Global, Inc. | 2 |
| Rion Acoustic Instruments, Inc. | 2 |
| 3D Systems, Inc. | 1 |
| Alliance Partners, LLC | 1 |
| Biomet Microfixation | 1 |
| Ceremed, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.