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

Scient'X — Predicate Candidate Screening

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

74 daysmedian FDA review time

175 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K071261	ISOBAR SEMI-RIGID DUAL DAMPENER	Scient'X	2008-04-17	349
K062912	SCIENT'X SPINAL SYSTEM	Scient'X	2007-02-05	131
K052763	STELLA CERVICAL PLATE	Scient'X	2005-11-10	41
K052367	SCIENT'X CEMENT RESTRICTOR	Scient'X	2005-10-05	37
K050348	CO VERTEBRAL BODY REPLACEMENT	Scient'X	2005-05-27	105
K051063	POLYAXIAL HEMISPHERICAL SPINAL SCREWS	Scient'X	2005-05-23	27
K043001	MX POLYAXIAL PEDICLE SCREW	Scient'X	2004-12-01	30
K042964	MX MONOAXIAL PEDICLE SCREW	Scient'X	2004-11-22	26
K042317	CERVICAL PLATE	Scient'X	2004-09-24	29
K040747	ALADYN RIGID SPINE PLATE	Scient'X	2004-06-17	86
K040454	BIOFILL BONE VOID FILLER	Scient'X	2004-05-07	74
K033109	ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS	Scient'X	2004-03-23	175

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