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

Altiva Corp. — Predicate Candidate Screening

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

73 daysmedian FDA review time

165 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K070891	ALTIVA CLASSIC ACP SYSTEM	Altiva Corp.	2007-06-11	73	0
K061482	ALTES BUTTRESS PLATING SYSTEM	Altiva Corp.	2006-07-26	57	0
K053070	CONTOUR II SPINAL SYSTEM	Altiva Corp.	2006-02-13	104	0
K051044	ARCTEC SEMIRIGID PLATING SYSTEM	Altiva Corp.	2005-10-07	165	0
K051216	HYDRALOK SYSTEM	Altiva Corp.	2005-07-19	68	1

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