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

U&I Corp., America · Predicate Candidate Screening

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

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K031585	U&I, OPTIMA, SPINAL SYSTEM	U&I Corp., America	2003-06-27	37	5
K031595	U & I AMERICA SPINAL HOOK SYSTEM	U&I Corp., America	2003-06-24	34	3
K024096	OPTIMA, SPINAL SYSTEM	U&I Corp., America	2003-03-12	90	3

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