Gbs Commonwealth Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 14
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K233839 | Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusio | December 20, 2023 |
| K233084 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusio | November 21, 2023 |
| K232292 | Peridot-EX Expandable Intervertebral Body Fusion System | November 7, 2023 |
| K232822 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical inter | October 13, 2023 |
| K230708 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical inter | May 22, 2023 |
| K213755 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusio | February 17, 2023 |
| K213980 | Peridot Spinal Interbody System | March 15, 2022 |
| K211205 | Prase-C Anterior Cervical Plate System | August 12, 2021 |
| K202872 | Prase PEEK Anterior Cervical Interbody Spacer | February 4, 2021 |
| K202878 | Prase-AP Anterior Cervical Plate System | January 29, 2021 |
| K192026 | Peridot Intervertebral body fusion System | November 26, 2019 |
| K190762 | The JASPER Spinal Fixation System II | June 19, 2019 |
| K182059 | Prase MIS Spinal System | October 4, 2018 |
| K173645 | JASPER Spinal Fixation System | July 23, 2018 |