Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Captiva Spine, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
119 daysmedian FDA review time
148 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K193270 | CapLOX II®/TowerLOX® MIS Pedicle Screw System | Captiva Spine, Inc. | 2020-01-31 | 66 | 0 |
| K181229 | TirboLOX-C Cervical IBFD | Captiva Spine, Inc. | 2018-09-19 | 133 | 0 |
| K180990 | TirboLOX-L Lumbar IBFD | Captiva Spine, Inc. | 2018-08-13 | 119 | 0 |
| K180475 | CapLOX II® / TowerLOX® MIS Pedicle Screw System | Captiva Spine, Inc. | 2018-03-19 | 25 | 0 |
| K120292 | CAPLOX II PEDICLE SCREW SYSTEM | Captiva Spine, Inc. | 2012-04-13 | 73 | 1 |
| K111115 | CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM | Captiva Spine, Inc. | 2011-09-13 | 145 | 0 |
| K110585 | CAPTIVA SPINE FUSELOX CERVICAL CAGE | Captiva Spine, Inc. | 2011-03-25 | 24 | 0 |
| K092017 | PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD) | Captiva Spine, Inc. | 2009-12-01 | 148 | 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