Atlas FDA

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

Signus Medical, LLC · Predicate Candidate Screening

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

89 daysmedian FDA review time
228 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K081108MONOPOLY PEDICLE SCREW SYSTEMSignus Medical, LLC2008-07-14870
K052096NUBIC SPINAL IMPLANTSignus Medical, LLC2005-08-16130
K031455CONKLUSION PEDICLE SCREW SYSTEMSignus Medical, LLC2003-10-221680
K031757PEEK TETRIS SPINAL IMPLANTSignus Medical, LLC2003-07-30540
K022793TETRIS SPINAL IMPLANTSignus Medical, LLC2003-04-082280
K020836RABEA CEMENT RESTRICTORSignus Medical, LLC2002-06-11890

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