Atlas FDA

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

Neurostructures, Inc. — Predicate Candidate Screening

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

112 daysmedian FDA review time
247 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.2020-09-242470
K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.2020-09-03660
K200927Transept Cervical Plate SystemNeurostructures, Inc.2020-07-241080
K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.2019-11-25980
K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.2018-11-09870
K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.2018-11-081430
K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.2018-03-291810
K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.2018-03-22340
K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.2018-02-262090
K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.2018-02-231470
K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.2017-10-251210
K171112Trifore(tm) Cervical Plating SystemNeurostructures, Inc.2017-06-08550
K153097Belvedere™ Lateral Plating SystemNeurostructures, Inc.2016-07-152630
K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.2015-02-251070
K142060TRANSOM ANTERIOR CERVICAL PLATENeurostructures, Inc.2014-11-181120

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