Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Solco Biomedical Co., Ltd. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
148 daysmedian FDA review time
539 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231655 | 4CIS® Chiron Spinal Fixation System | Solco Biomedical Co., Ltd. | 2024-11-26 | 539 | 0 |
| K203233 | 4CIS Chiron Spinal Fixation System | Solco Biomedical Co., Ltd. | 2022-06-01 | 576 | 0 |
| K192044 | 4CIS Marlin PEEK ACIF Cage | Solco Biomedical Co., Ltd. | 2019-12-19 | 141 | 0 |
| K190563 | 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS | Solco Biomedical Co., Ltd. | 2019-09-18 | 197 | 0 |
| K190471 | 4CIS® Chiron Spinal Fixation System | Solco Biomedical Co., Ltd. | 2019-07-24 | 148 | 0 |
| K182489 | 4CIS® Pinehurst Anterior Cervical Plate system | Solco Biomedical Co., Ltd. | 2019-01-16 | 127 | 0 |
| K162402 | 4CIS® Marlin ACIF Cage System | Solco Biomedical Co., Ltd. | 2017-02-16 | 174 | 0 |
| K121615 | 4CIS VANE SPINE SYSTEM | Solco Biomedical Co., Ltd. | 2012-08-15 | 75 | 0 |
| K102458 | 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM | Solco Biomedical Co., Ltd. | 2011-06-13 | 290 | 0 |
| K101818 | 4CIS VANE SPINE SYSTEM | Solco Biomedical Co., Ltd. | 2011-02-11 | 226 | 0 |
| K092162 | 4CIS PEEK, PLIF AND TLIF CAGE SYSTEM | Solco Biomedical Co., Ltd. | 2010-01-06 | 174 | 0 |
| K081145 | MODIFICATION TO 4CIS VANE SPINE SYSTEM | Solco Biomedical Co., Ltd. | 2008-11-05 | 197 | 0 |
| K082453 | 4CIS SOLAR AND APOLLON SPINE SYSTEMS | Solco Biomedical Co., Ltd. | 2008-09-23 | 29 | 0 |
| K060702 | 4CIS VANE SPINE SYSTEM | Solco Biomedical Co., Ltd. | 2006-06-22 | 98 | 0 |
| K051155 | SOLCO 4CIS GENERAL PLATE SYSTEM | Solco Biomedical Co., Ltd. | 2005-07-11 | 68 | 0 |
| K050471 | 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM | Solco Biomedical Co., Ltd. | 2005-05-12 | 78 | 0 |
| K043578 | THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM | Solco Biomedical Co., Ltd. | 2005-03-07 | 69 | 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