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

Zavation, LLC — Predicate Candidate Screening

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

111 daysmedian FDA review time

242 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K162206	Zavation IBF	Zavation, LLC	2017-04-04	242
K162575	Z-LINKPC System	Zavation, LLC	2017-03-03	169
K162824	Z-Span Plate System	Zavation, LLC	2017-02-17	133
K161016	Z-Clamp ISP System	Zavation, LLC	2016-10-19	191
K153404	Zavation Spinal System	Zavation, LLC	2016-04-21	149
K160362	Z-Span Plate System	Zavation, LLC	2016-03-22	42
K142392	Zavation Posterior LEIF	Zavation, LLC	2015-04-29	245
K142271	Zavation Z-Link Lumbar	Zavation, LLC	2014-12-19	126
K141419	ZVPLASTY	Zavation, LLC	2014-09-12	106
K141005	Z-LINK CERVICAL	Zavation, LLC	2014-08-07	111
K130030	ZAVATION CERVICAL PLATE SYSTEM	Zavation, LLC	2013-04-25	111
K120576	ZAVATION IBF SYSTEM	Zavation, LLC	2012-03-28	30
K112664	ZAVATION IBF SYSTEMS	Zavation, LLC	2011-12-23	101
K112533	ZAVATION CERVICAL PLATE SYSTEM	Zavation, LLC	2011-12-08	101
K112484	ZAVATION SPINAL SYSTEM	Zavation, LLC	2011-11-22	85

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