Atlas FDA

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

Benvenue Medical, Inc. · Predicate Candidate Screening

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

145 daysmedian FDA review time
230 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.2020-10-211450
K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.2020-07-022300
K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.2019-05-231540
K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.2016-11-17780
K142023LUNA INTERBODY SYSTEMBenvenue Medical, Inc.2014-11-201180
K141141KIVA VCF TREATMENT SYSTEMBenvenue Medical, Inc.2014-08-141040
K132817KIVA VCF TREATMENT SYSTEMBenvenue Medical, Inc.2014-01-241370
K070293BENVENUE VCF OSTEO COIL SYSTEMBenvenue Medical, Inc.2007-07-101600

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