Atlas FDA

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

Apollo Spine, Inc. — Predicate Candidate Screening

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

214 daysmedian FDA review time
259 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K120340VENUS FACET SCREW SYSTEMApollo Spine, Inc.2012-10-192590
K102636ZENITH PEDICLE SYSTEMApollo Spine, Inc.2011-03-031710
K102121ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBARApollo Spine, Inc.2011-01-121670
K101588ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICALApollo Spine, Inc.2011-01-072140
K090751COMET ANTERIOR CERVICAL PLATE SYSTEMApollo Spine, Inc.2009-10-232170
K082504APOLLO ANTERIOR CERVICAL PLATE SYSTEMApollo Spine, Inc.2009-01-271510

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