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

Eisertech, LLC — Predicate Candidate Screening

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

112 daysmedian FDA review time

436 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K192768	Temporary Fixation Pins	Eisertech, LLC	2019-12-26	87	0
K190565	Cervical Plate	Eisertech, LLC	2019-05-31	87	0
K140348	INTERBODY CAGE	Eisertech, LLC	2015-04-23	436	0
K142576	Spinal System	Eisertech, LLC	2015-02-26	167	1
K122444	CERVICAL CAGE	Eisertech, LLC	2012-08-30	20	0
K113170	CERVICAL PLATE	Eisertech, LLC	2012-04-06	162	0
K113478	PLIF CAGE	Eisertech, LLC	2012-03-05	103	0
K110915	CERVICAL CAGE	Eisertech, LLC	2011-07-22	112	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