Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gbs Commonwealth Co., Ltd. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
98 daysmedian FDA review time
238 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233839 | Peridot-PT Anterior Cervical Intervertebral body fusion Syst | Gbs Commonwealth Co., Ltd. | 2023-12-20 | 16 | 0 |
| K233084 | Peridot-PT Anterior Cervical Intervertebral body fusion Syst | Gbs Commonwealth Co., Ltd. | 2023-11-21 | 56 | 0 |
| K232292 | Peridot-EX Expandable Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 2023-11-07 | 98 | 0 |
| K232822 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body | Gbs Commonwealth Co., Ltd. | 2023-10-13 | 30 | 0 |
| K230708 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body | Gbs Commonwealth Co., Ltd. | 2023-05-22 | 69 | 0 |
| K213755 | Peridot-PT Anterior Cervical Intervertebral body fusion Syst | Gbs Commonwealth Co., Ltd. | 2023-02-17 | 444 | 0 |
| K213980 | Peridot Spinal Interbody System | Gbs Commonwealth Co., Ltd. | 2022-03-15 | 85 | 0 |
| K211205 | Prase-C Anterior Cervical Plate System | Gbs Commonwealth Co., Ltd. | 2021-08-12 | 112 | 0 |
| K202872 | Prase PEEK Anterior Cervical Interbody Spacer | Gbs Commonwealth Co., Ltd. | 2021-02-04 | 129 | 0 |
| K202878 | Prase-AP Anterior Cervical Plate System | Gbs Commonwealth Co., Ltd. | 2021-01-29 | 123 | 0 |
| K192026 | Peridot Intervertebral body fusion System | Gbs Commonwealth Co., Ltd. | 2019-11-26 | 120 | 0 |
| K190762 | The JASPER Spinal Fixation System II | Gbs Commonwealth Co., Ltd. | 2019-06-19 | 86 | 0 |
| K182059 | Prase MIS Spinal System | Gbs Commonwealth Co., Ltd. | 2018-10-04 | 65 | 0 |
| K173645 | JASPER Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 2018-07-23 | 238 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda