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

Vertiflex, Inc. — Predicate Candidate Screening

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

88 daysmedian FDA review time
152 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K122509VERTIFLEX SPINOUS PROCESS FIXATION PLATEVertiflex, Inc.2012-12-171220
K122662VERTIFLEX DIRECT DECOMPRESSION SYSTEMVertiflex, Inc.2012-11-13740
K082270OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEMVertiflex, Inc.2008-09-16360
K073143MODIFIED VERTIFLEX SPINAL SCREW SYSTEMVertiflex, Inc.2008-04-071520
K073245EXTENDED VERTIFLEX SPINAL SCREW SYSTEMVertiflex, Inc.2008-02-15880

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