Atlas FDA

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

Kalitec Direct, LLC — Predicate Candidate Screening

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

95 daysmedian FDA review time
177 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC2018-06-141200
K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC2017-10-25370
K172086Matira™ Anterior Cervical SystemKalitec Direct, LLC2017-09-22730
K170342Ocata Anterior Cervical SystemKalitec Direct, LLC2017-05-09950
K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC2017-03-16940
K140678COSMOLOCK PEDICLE SCREW SYSTEMKalitec Direct, LLC2014-06-19930
K133815INTESS CERVICAL CAGE SYSTEMKalitec Direct, LLC2014-04-161210
K123100INTESS LUMBAR CAGEKalitec Direct, LLC2013-03-281770
K111370ODALYS PEDICLE SCREW SYSTEMKalitec Direct, LLC2011-09-211280

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