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

U&I Corporation — Predicate Candidate Screening

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

104 daysmedian FDA review time

255 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days
K220147	Aspiron S ACP System	U&I Corporation	2022-02-16	28
K210573	Velofix SA Cervical Cage	U&I Corporation	2021-11-19	266
K183243	Velofix TLIF Cage	U&I Corporation	2019-07-10	231
K190067	Velofix Interbody Fusion System	U&I Corporation	2019-02-04	20
K190053	SECULOK™ ACP System	U&I Corporation	2019-02-01	21
K181824	CBT Screw Fixation System	U&I Corporation	2018-12-13	157
K183383	ANAX™ OCT Spinal System	U&I Corporation	2018-12-12	6
K181829	Velofix TLIF Cage	U&I Corporation	2018-11-14	128
K182055	SECULOK™ ACP System	U&I Corporation	2018-09-10	41
K180759	SECULOK™ Suture Anchor	U&I Corporation	2018-08-09	140
K173198	Facet Screw Fixation System	U&I Corporation	2018-01-03	93
K173524	ANAX 5.5™ Spinal System	U&I Corporation	2017-12-13	29
K172419	Velofix™ TLIF Cage	U&I Corporation	2017-12-04	116
K172424	Velofix™ SA Cervical Cage	U&I Corporation	2017-11-22	104
K171749	Velofix(tm) Interbody Fusion System	U&I Corporation	2017-07-13	30
K162189	ANAX™ 5.5 Spinal System	U&I Corporation	2016-08-30	26
K143631	Benefix Interspinous Fixation System	U&I Corporation	2015-09-03	255
K150570	ANAX OCT Spinal System	U&I Corporation	2015-06-03	89
K143417	ANAX 5.5 Spinal System	U&I Corporation	2015-02-25	89
K132797	L'DISQ	U&I Corporation	2014-07-30	327
K132218	PERFIX ILIAC SCREW SYSTEM	U&I Corporation	2013-12-17	153
K132101	ANAX 5.5 SPINAL SYSTEM	U&I Corporation	2013-11-25	140
K131200	ASPIRON ACP SYSTEM	U&I Corporation	2013-08-29	122

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