Atlas FDA

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

Allez Spine, LLC · Predicate Candidate Screening

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

113 daysmedian FDA review time
285 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K091995LAGUNA SIZE 8 PEDICLE SCREW SYSTEMAllez Spine, LLC2009-08-07360
K091219DEL MAR MONOAXIAL PEDICLE SCREW SYSTEMAllez Spine, LLC2009-07-09730
K083826LAGUNA POLYAXIAL PEDICLE SCREW SYSTEMAllez Spine, LLC2009-01-22300
K072678LAGUNA SIZE 8 PEDICLE SCREWAllez Spine, LLC2008-07-022850
K070460ALLEZ SPINE CROSS CONNECTORSAllez Spine, LLC2007-06-111151
K051275LAGUNA MONOAXIAL PEDICLE SCREW SYSTEMAllez Spine, LLC2005-12-0920621
K050060LAGUNA PEDICLE SCREW SYSTEMAllez Spine, LLC2005-05-0411327

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