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

Clariance, Sas — Predicate Candidate Screening

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

100 daysmedian FDA review time

149 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K202032	Idys LLIF 3DTi	Clariance, Sas	2021-04-01	253
K202956	Erisma LP Navigated Instruments	Clariance, Sas	2021-02-26	149
K200920	Idys ALIF ZP 3DTi	Clariance, Sas	2020-05-29	53
K192168	Idys ALIF ZP 3DTi	Clariance, Sas	2019-11-04	87
K191263	Idys ALIF TiVac	Clariance, Sas	2019-06-06	27
K183259	Idys™ TLIF TiVac	Clariance, Sas	2019-03-01	100
K172465	Idys™ TLIF 3DTi Cages	Clariance, Sas	2017-12-15	123
K172083	Idys™ ALIF System	Clariance, Sas	2017-11-08	121
K170163	Erisma® LP Spinal Fixation System	Clariance, Sas	2017-02-14	27
K162367	Erisma® LP MIS	Clariance, Sas	2016-10-27	65
K153326	Erisma-LP Spinal Fixation System	Clariance, Sas	2016-03-08	110

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