Company ยท KR
Gbs Commonwealth Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2023. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 20, 2023 | K233839 | Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Perido Gbs Commonwealth Co., Ltd., KR | ODP |
| Nov 21, 2023 | K233084 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system Gbs Commonwealth Co., Ltd., KR | ODP |
| Nov 7, 2023 | K232292 | Peridot-EX Expandable Intervertebral Body Fusion System Gbs Commonwealth Co., Ltd., KR | MAX |
| Oct 13, 2023 | K232822 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF ( Gbs Commonwealth Co., Ltd., KR | ODP |
| May 22, 2023 | K230708 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical interbody fusion-ACIF (Th Gbs Commonwealth Co., Ltd., KR | ODP |
| Feb 17, 2023 | K213755 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system Gbs Commonwealth Co., Ltd., KR | ODP |
| Mar 15, 2022 | K213980 | Peridot Spinal Interbody System Gbs Commonwealth Co., Ltd., KR | ODP |
| Aug 12, 2021 | K211205 | Prase-C Anterior Cervical Plate System Gbs Commonwealth Co., Ltd., KR | KWQ |
| Feb 4, 2021 | K202872 | Prase PEEK Anterior Cervical Interbody Spacer Gbs Commonwealth Co., Ltd., KR | ODP |
| Jan 29, 2021 | K202878 | Prase-AP Anterior Cervical Plate System Gbs Commonwealth Co., Ltd., KR | KWQ |
| Nov 26, 2019 | K192026 | Peridot Intervertebral body fusion System Gbs Commonwealth Co., Ltd., KR | MAX |
| Jun 19, 2019 | K190762 | The JASPER Spinal Fixation System II Gbs Commonwealth Co., Ltd., KR | NKB |
| Oct 4, 2018 | K182059 | Prase MIS Spinal System Gbs Commonwealth Co., Ltd., KR | NKB |
| Jul 23, 2018 | K173645 | JASPER Spinal Fixation System Gbs Commonwealth Co., Ltd., KR | NKB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||