FDA 510(k) Applications Submitted by GBS Commonwealth Co., Ltd.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K230708 |
03/14/2023 |
Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical interbody fusion-ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) |
GBS Commonwealth Co., Ltd. |
| K190762 |
03/25/2019 |
The JASPER Spinal Fixation System II |
GBS Commonwealth Co., Ltd. |
| K211205 |
04/22/2021 |
Prase-C Anterior Cervical Plate System |
GBS Commonwealth Co., Ltd. |
| K192026 |
07/29/2019 |
Peridot Intervertebral body fusion System |
GBS Commonwealth Co., Ltd. |
| K182059 |
07/31/2018 |
Prase MIS Spinal System |
GBS Commonwealth Co., Ltd. |
| K202872 |
09/28/2020 |
Prase PEEK Anterior Cervical Interbody Spacer |
GBS Commonwealth Co., Ltd. |
| K202878 |
09/28/2020 |
Prase-AP Anterior Cervical Plate System |
GBS Commonwealth Co., Ltd. |
| K173645 |
11/27/2017 |
JASPER Spinal Fixation System |
GBS Commonwealth Co., Ltd. |
| K213755 |
11/30/2021 |
Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system |
GBS Commonwealth Co., Ltd. |
| K213980 |
12/20/2021 |
Peridot Spinal Interbody System |
GBS Commonwealth Co., Ltd. |
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