Atlas FDA

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

Vertebral Technologies, Inc. — Predicate Candidate Screening

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

56 daysmedian FDA review time
122 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K131540INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICEVertebral Technologies, Inc.2013-09-03970
K110226INTERFUSE T INVERTEBRAL BODY FUSION DEVICEVertebral Technologies, Inc.2011-05-271220
K110045INTERFUSE DA INVERTEBRAL BODY FUSION DEVICEVertebral Technologies, Inc.2011-02-03280
K102277INTERFUSE T INVERTEBRAL BODY FUSION DEVICEVertebral Technologies, Inc.2010-10-06560
K093675INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076Vertebral Technologies, Inc.2009-12-23260
K091988MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICEVertebral Technologies, Inc.2009-07-30280
K080673INTERFUSE INTERVERTEBRAL BODY FUSION DEVICEVertebral Technologies, Inc.2008-06-10920

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