Atlas FDA

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

Nvision Biomedical Technologies, LLC — Predicate Candidate Screening

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

74 daysmedian FDA review time
163 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K182943VERTEX Nitinol Staple SystemNvision Biomedical Technologies, LLC2019-04-041630
K183055Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC2019-02-191090
K182949Healix™ Compression Screw SystemNvision Biomedical Technologies, LLC2018-12-04420
K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC2018-04-17560
K173091Boundary Anterior Lumbar Buttress PlateNvision Biomedical Technologies, LLC2017-12-06680
K170074nvcNvision Biomedical Technologies, LLC2017-01-24150
K162426nva, nvp, and nvtNvision Biomedical Technologies, LLC2016-09-29300
K161524Tangis Anterior Cervical PlateNvision Biomedical Technologies, LLC2016-09-02920
K142328nvcNvision Biomedical Technologies, LLC2014-12-231250
K142594nva, nvp, nvtNvision Biomedical Technologies, LLC2014-11-28740

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