Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GS Medical Co., Ltd. · Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
124 daysmedian FDA review time
283 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243073 | AnyPlus Navigated Instruments System | GS Medical Co., Ltd. | 2024-12-06 | 70 | 0 |
| K241738 | PYXIS 3D Titanium Cervical Cage system | GS Medical Co., Ltd. | 2024-08-20 | 64 | 0 |
| K240350 | AnyPlus II Spinal Fixation System | GS Medical Co., Ltd. | 2024-04-03 | 58 | 0 |
| K231808 | QUASAR Standalone ACIF System | GS Medical Co., Ltd. | 2023-07-20 | 30 | 0 |
| K223868 | PYXIS 3D Titanium Cage System | GS Medical Co., Ltd. | 2023-04-26 | 124 | 0 |
| K222041 | CYGNUS-C Standalone ACIF System | GS Medical Co., Ltd. | 2023-02-09 | 213 | 0 |
| K221687 | Pegasus-X Expandable PLIF System | GS Medical Co., Ltd. | 2022-07-27 | 47 | 0 |
| K211797 | TRACKER Plus Kyphoplasty System | GS Medical Co., Ltd. | 2021-10-28 | 140 | 0 |
| K200592 | GS Medical AnyPlus PEEK Cage System | GS Medical Co., Ltd. | 2020-08-10 | 157 | 0 |
| K192335 | TRACKER Kyphoplasty System | GS Medical Co., Ltd. | 2019-12-04 | 98 | 0 |
| K190170 | MVP Cervical Plate System | GS Medical Co., Ltd. | 2019-05-13 | 101 | 0 |
| K172546 | AnyPlus® Spinal Fixation System | GS Medical Co., Ltd. | 2017-10-23 | 61 | 0 |
| K153517 | AnyPlus® Cervical PEEK Cage System | GS Medical Co., Ltd. | 2016-06-24 | 199 | 0 |
| K131612 | ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES | GS Medical Co., Ltd. | 2014-04-18 | 319 | 0 |
| K111354 | GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF) | GS Medical Co., Ltd. | 2011-10-17 | 157 | 0 |
| K100516 | ANYPLUS PEEK CAGES | GS Medical Co., Ltd. | 2010-12-03 | 283 | 0 |
| K091717 | ANY PLUS SPINAL FIXATION SYSTEM | GS Medical Co., Ltd. | 2010-01-25 | 228 | 0 |
| K053573 | GSS PEDICLE SCREW SYSTEM | GS Medical Co., Ltd. | 2006-03-08 | 76 | 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