Atlas FDA

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

Omnia Medical, LLC — Predicate Candidate Screening

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

86 daysmedian FDA review time
371 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC2025-06-062940
K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC2024-04-24500
K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; OmniaOmnia Medical, LLC2023-04-12540
K223321Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC2023-03-131330
K212612Omnia Medical TiBrid-SCOmnia Medical, LLC2022-11-154550
K203207Omnia Medical TiBrid-SAOmnia Medical, LLC2020-12-23542
K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC2020-02-272060
K190363Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid LatOmnia Medical, LLC2020-02-213710
K191778Omnia Medical VBROmnia Medical, LLC2019-08-28570
K183659Omnia Medical Rotary PLIF SystemOmnia Medical, LLC2019-02-06410
K172323Omnia Medical VBROmnia Medical, LLC2017-10-26860

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