Home › Device types › GXN
Plate, Cranioplasty, Preformed, Non-Alterable
FDA product code GXN · Class 2 · Neurology
7,111
Registered devices
824
Adverse events
11
Recalls
57
510(k) clearances
Devices with this code
HTR-PEKK — OXFORD PERFORMANCE MATERIALS, INC.HTR-PEKK — OXFORD PERFORMANCE MATERIALS, INC.HTR-PEKK — OXFORD PERFORMANCE MATERIALS, INC.NA — Synthes GmbHKELYNIAM CSI — KELYNIAM GLOBAL, INC.KELYNIAM CSI — KELYNIAM GLOBAL, INC.KELYNIAM CSI — KELYNIAM GLOBAL, INC.HTR-PEKK — OXFORD PERFORMANCE MATERIALS, INC.HTR-PEKK — OXFORD PERFORMANCE MATERIALS, INC.HTR-PEKK — OXFORD PERFORMANCE MATERIALS, INC.Kelyniam CSI — KELYNIAM GLOBAL, INC.Kelyniam CSI — KELYNIAM GLOBAL, INC.HTR-PEKK — OXFORD PERFORMANCE MATERIALS, INC.Bioplate® — Bioplate, Inc.KELYNIAM CSI — KELYNIAM GLOBAL, INC.HTR-PEKK — OXFORD PERFORMANCE MATERIALS, INC.HTR-PEKK — OXFORD PERFORMANCE MATERIALS, INC.Kelyniam CSI — KELYNIAM GLOBAL, INC.LEVEL ONE THORACIC, STERILE — KLS-Martin L.P.HTR-PEKK — OXFORD PERFORMANCE MATERIALS, INC.HTR-PEKK — OXFORD PERFORMANCE MATERIALS, INC.CranioFit — Bioplate, Inc.KELYNIAM CSI — KELYNIAM GLOBAL, INC.HTR-PEKK — OXFORD PERFORMANCE MATERIALS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-08-22 | Zimmer Biomet, Inc. | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. |
| 2018-08-22 | Zimmer Biomet, Inc. | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. |
| 2018-08-22 | Zimmer Biomet, Inc. | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. |
| 2018-08-22 | Zimmer Biomet, Inc. | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. |
| 2018-08-22 | Zimmer Biomet, Inc. | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. |
| 2018-08-22 | Zimmer Biomet, Inc. | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. |
| 2017-06-10 | Kelyniam Global, Inc. | Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding sut |
| 2017-06-10 | Kelyniam Global, Inc. | Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding sut |
| 2017-06-10 | Kelyniam Global, Inc. | Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding sut |
| 2017-06-10 | Kelyniam Global, Inc. | Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding sut |
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