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

U&I Corp. — Predicate Candidate Screening

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

124 daysmedian FDA review time

203 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K140864	VELOXTM INTERBODY FUSION SYSTEM	U&I Corp.	2014-07-22	110
K140234	ASPIRON ACP SYSTEM	U&I Corp.	2014-06-02	124
K132926	VELOFIXTM INTERBODY FUSION SYSTEM	U&I Corp.	2014-03-05	168
K120419	DYNA LOCKING ANKLE NAIL	U&I Corp.	2012-05-21	101
K112240	DYNA LOCKING CANNULATED SCREW	U&I Corp.	2012-01-04	153
K102367	OPTIGEN TOTAL KNEE SYSTEM	U&I Corp.	2010-12-08	110
K093707	DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820	U&I Corp.	2010-06-23	203
K092771	DYNA LOCKING IM NAIL	U&I Corp.	2009-12-02	84
K091725	PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN30	U&I Corp.	2009-11-09	151
K061002	MAXIMA ANTERIOR CERVICAL PLATE SYSTEM	U&I Corp.	2006-11-15	218
K051971	OPTIMA SPINAL SYSTEM	U&I Corp.	2005-08-04	14
K042928	MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM	U&I Corp.	2005-02-17	118

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