Gbs Commonwealth Co., Ltd.
FDA Regulatory Profile
Gbs Commonwealth Co., Ltd. has 0 FDA recalls, 1 inspection, 14 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Feb 20, 2020 · OAI
- Latest 510(k)
- Dec 20, 2023
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 14 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 1 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Feb 20, 2020 | Geumcheon, Korea (The Republic Of) | Devices | Official Action Indicated (OAI) | 3015136700 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3015136700 | Geumcheon, Korea (The Republic Of) | 1 | Feb 20, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K233839 | Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body… | Dec 20, 2023 |
| K233084 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body… | Nov 21, 2023 |
| K232292 | Peridot-EX Expandable Intervertebral Body Fusion System | Nov 7, 2023 |
| K232822 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical… | Oct 13, 2023 |
| K230708 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical… | May 22, 2023 |
| K213755 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body… | Feb 17, 2023 |
| K213980 | Peridot Spinal Interbody System | Mar 15, 2022 |
| K211205 | Prase-C Anterior Cervical Plate System | Aug 12, 2021 |
| K202872 | Prase PEEK Anterior Cervical Interbody Spacer | Feb 4, 2021 |
| K202878 | Prase-AP Anterior Cervical Plate System | Jan 29, 2021 |
| K192026 | Peridot Intervertebral body fusion System | Nov 26, 2019 |
| K190762 | The JASPER Spinal Fixation System II | Jun 19, 2019 |
| K182059 | Prase MIS Spinal System | Oct 4, 2018 |
| K173645 | JASPER Spinal Fixation System | Jul 23, 2018 |