Atlas FDA

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

Nanovis, LLC — Predicate Candidate Screening

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

95 daysmedian FDA review time
266 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K241605Adaptix™ PEEK Interbody System with Nanotechnology; CapstoneNanovis, LLC2024-09-05930
K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC2023-06-02600
K203452Nano FortiFix® SystemNanovis, LLC2020-12-22290
K191822Nano FortiCore, FortiCoreNanovis, LLC2019-10-11950
K171312FortiCore®Nanovis, LLC2018-01-222630
K161485Nanovis Intervertebral Body Fusion System and Forticore(R)Nanovis, LLC2016-09-06980
K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC2016-06-28900
K140280FORTICORENanovis, LLC2014-09-052130
K113173NANOVIS SPINAL SYSTEMNanovis, LLC2012-01-19840
K110442NANOVIS INTERVERTEBRAL BODY FUSION SYSTEMNanovis, LLC2011-11-092660

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