Atlas FDA

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

Us Spine — Predicate Candidate Screening

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

84 daysmedian FDA review time
99 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K082801PHANTOM PLUS CAGE SYSTEMUs Spine2008-12-22890
K081883MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEMUs Spine2008-09-24840
K081296PREFERENCE PEDICLE SCREW SYSTEMUs Spine2008-06-06300
K062785LTD POLYAXIAL FIXATION SYSTEMUs Spine2006-12-26990
K061041US SPINE FACET FIXATION SYSTEMUs Spine2006-06-19660

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