Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medyssey Co, Ltd. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
127 daysmedian FDA review time
267 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260036 | NeckTune™ 3D SA Cervical Cage | Medyssey Co, Ltd. | 2026-06-15 | 160 | 0 |
| K242806 | Medyssey Navigation System | Medyssey Co, Ltd. | 2025-04-16 | 211 | 0 |
| K121670 | MEDYSSEY CANNULATED PEDICLE SCREW | Medyssey Co, Ltd. | 2013-01-25 | 233 | 0 |
| K121320 | C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE | Medyssey Co, Ltd. | 2012-08-10 | 100 | 0 |
| K121246 | MEDYSSY LT CAGE SYSTEM | Medyssey Co, Ltd. | 2012-06-15 | 51 | 0 |
| K110284 | NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM | Medyssey Co, Ltd. | 2011-06-08 | 127 | 0 |
| K110283 | ZENIUS SPINAL SYSTEM | Medyssey Co, Ltd. | 2011-05-19 | 107 | 0 |
| K110067 | LP CAGE | Medyssey Co, Ltd. | 2011-04-08 | 88 | 0 |
| K103272 | ZENIUS SPINAL SYSTEM | Medyssey Co, Ltd. | 2010-12-29 | 54 | 0 |
| K103147 | NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM | Medyssey Co, Ltd. | 2010-12-16 | 52 | 0 |
| K093104 | MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM | Medyssey Co, Ltd. | 2010-06-25 | 267 | 0 |
| K081153 | NOVEL SPINAL SYSTEM | Medyssey Co, Ltd. | 2009-01-30 | 282 | 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