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

Renovis Surgical Technologies · Predicate Candidate Screening

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

133 daysmedian FDA review time
174 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K190122Renovis A200 PS Knee System as part of the Renovis A200 KneeRenovis Surgical Technologies2019-06-201460
K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SyRenovis Surgical Technologies2018-12-071330
K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies2018-09-11810
K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies2017-11-161740
K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies2017-08-081340
K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF)Renovis Surgical Technologies2016-03-161280
K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015-02-06980

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