Atlas FDA

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

Advanced Medical Technologies AG · Predicate Candidate Screening

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

85 daysmedian FDA review time
309 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K121330WAVE O CAGEAdvanced Medical Technologies AG2012-06-29570
K121288FUSE CAGEAdvanced Medical Technologies AG2012-06-29600
K121332LOOP CAGEAdvanced Medical Technologies AG2012-06-29570
K121333WAVE D CAGEAdvanced Medical Technologies AG2012-06-29570
K100945FUSE PLIF CAFEAdvanced Medical Technologies AG2011-02-093090
K080401SHELL CAGE, WAVE CAGE, LOOP CAGEAdvanced Medical Technologies AG2008-05-09850
K033148ART ANTERIOR SPINAL SYSTEMAdvanced Medical Technologies AG2004-04-121950
K033150ART POSTERIOR SPINAL SYSTEMAdvanced Medical Technologies AG2004-03-011530

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