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

Trans1 Incorporated — Predicate Candidate Screening

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

124 daysmedian FDA review time

213 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K120991	TRANS1 INTERBODY FUSION SYSTEM	Trans1 Incorporated	2012-08-23	143
K102334	TRANS1 AXIALIF PLUS	Trans1 Incorporated	2011-03-14	209
K100210	TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T	Trans1 Incorporated	2010-08-26	213
K092124	AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF	Trans1 Incorporated	2010-01-21	190
K073643	TRANS1 AXIALIF 2-LEVEL OR II SYSTEM	Trans1 Incorporated	2008-04-28	124
K073515	TRANS1 FACET SCREW	Trans1 Incorporated	2008-03-11	88
K073514	TRANS1 AXIAL FIXATON SYSTEM	Trans1 Incorporated	2008-01-11	28
K051856	TRANS1 FACET SCREWS	Trans1 Incorporated	2005-09-26	80
K050965	TRANS1 AXIALIF SYSTEM	Trans1 Incorporated	2005-06-14	57

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