Gbs Commonwealth Co., Ltd.
Geumcheon-Gu, KR
Gbs Commonwealth Co., Ltd. appears in FDA device records in Geumcheon-Gu, KR. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Gbs Commonwealth Co., Ltd. between 2018 and 2023. The busiest year on record is 2023, with 6. The most recent is 2023, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 2 |
| 2019 | 2 |
| 2021 | 3 |
| 2022 | 1 |
| 2023 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | Substantially Equivalent | |
| K233084 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system | ODP | Substantially Equivalent | |
| K232292 | Peridot-EX Expandable Intervertebral Body Fusion System | MAX | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K213755 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system | ODP | Substantially Equivalent | |
| K213980 | Peridot Spinal Interbody System | ODP | Substantially Equivalent | |
| K211205 | Prase-C Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K202872 | Prase PEEK Anterior Cervical Interbody Spacer | ODP | Substantially Equivalent | |
| K202878 | Prase-AP Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K192026 | Peridot Intervertebral body fusion System | MAX | Substantially Equivalent | |
| K190762 | The JASPER Spinal Fixation System II | NKB | Substantially Equivalent | |
| K182059 | Prase MIS Spinal System | NKB | Substantially Equivalent | |
| K173645 | JASPER Spinal Fixation System | NKB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain