Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Captiva Spine — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

71 daysmedian FDA review time
386 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine2016-03-02570
K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine2015-06-26600
K141332Captiva Spine SmartLOX Cervical Plate SystemCaptiva Spine2015-06-113860
K142586Captiva Spine FuselOX Cervical IBF SystemCaptiva Spine2015-05-282550
K131538CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEMCaptiva Spine2013-08-08710
K122956FUSELOX LUMBAR INTERBODY FUSION DEVICECaptiva Spine2012-10-25300
K122332TOWERLOX PEDICLE SCREW SYSTEMCaptiva Spine2012-10-16750

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