Atlas FDA

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

NGMedical GmbH · Predicate Candidate Screening

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

154 daysmedian FDA review time
343 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261067BEE PLIF CageNGMedical GmbH2026-04-30290
K250560BEE HANGMedical GmbH2025-11-212690
K231371BEE Cervical CageNGMedical GmbH2024-01-122450
K212050NGM WAVE PLIF CageNGMedical GmbH2021-12-011540
K211413BEE PLIF CageNGMedical GmbH2021-08-271130
K203444BEE HA CageNGMedical GmbH2021-03-181150
K200429BEE CagesNGMedical GmbH2021-01-293430

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