Gbs Commonwealth Co., Ltd.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Gbs Commonwealth Co., Ltd.” (first 2018, latest 2023), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 92 days. Since 2017 the median was 92 days, against 89 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 2 | 152 |
| 2019 | 2 | 103 |
| 2020 | 0 | — |
| 2021 | 3 | 123 |
| 2022 | 1 | 85 |
| 2023 | 6 | 62 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Gbs Commonwealth Co., Ltd. took a median 92 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 89 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 7 | 7 |
| NKB | Thoracolumbosacral Pedicle Screw System | 3 | 3 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
Review panels
- Orthopedic (14)
Most recent Gbs Commonwealth Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233839 | Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion system | ODP | 2023-12-20 | 16 |
| K233084 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system | ODP | 2023-11-21 | 56 |
| K232292 | Peridot-EX Expandable Intervertebral Body Fusion System | MAX | 2023-11-07 | 98 |
| K232822 | 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) | ODP | 2023-10-13 | 30 |
| K230708 | 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) | ODP | 2023-05-22 | 69 |
| K213755 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system | ODP | 2023-02-17 | 444 |
| K213980 | Peridot Spinal Interbody System | ODP | 2022-03-15 | 85 |
| K211205 | Prase-C Anterior Cervical Plate System | KWQ | 2021-08-12 | 112 |
| K202872 | Prase PEEK Anterior Cervical Interbody Spacer | ODP | 2021-02-04 | 129 |
| K202878 | Prase-AP Anterior Cervical Plate System | KWQ | 2021-01-29 | 123 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Gbs Commonwealth Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Gbs Commonwealth Co., Ltd.?
FDA lists 14 510(k) clearances under the applicant name “Gbs Commonwealth Co., Ltd.” (first 2018, latest 2023), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Gbs Commonwealth Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gbs Commonwealth Co., Ltd. is 92 days. Since 2017: 92 days, versus 89 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Gbs Commonwealth Co., Ltd.?
The most frequent FDA product codes under this applicant name are ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 7); NKB (Thoracolumbosacral Pedicle Screw System, 3); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2).
Next steps
- See all 14 Gbs Commonwealth Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code ODP, Gbs Commonwealth Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.