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

Seaspine — Predicate Candidate Screening

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

69 daysmedian FDA review time

90 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K043232	UCR SPINAL SYSTEM	Seaspine	2004-12-21	29	1
K040130	ANTERIOR LUMBAR BUTTRESS SYSTEM	Seaspine	2004-03-26	65	0
K032739	UCR SPINAL SYSTEM	Seaspine	2003-11-20	77	0
K032368	SONOMA ANTERIOR CERVICAL PLATE SYSTEM	Seaspine	2003-10-09	69	0
K031381	UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUM	Seaspine	2003-07-30	90	0

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