Atlas FDA

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

Renovis Surgical Technologies, Inc. · Predicate Candidate Screening

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

98 daysmedian FDA review time
140 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.2018-06-141080
K152193Renovis Anterior Cervical Plate SystemRenovis Surgical Technologies, Inc.2015-09-25510
K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.2015-05-111400
K141676RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEMRenovis Surgical Technologies, Inc.2014-11-041340
K142095RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEMRenovis Surgical Technologies, Inc.2014-10-15750
K141370RENOVIS CEMENTED HIP SYSTEMRenovis Surgical Technologies, Inc.2014-09-02980
K140106S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEMRenovis Surgical Technologies, Inc.2014-03-27710

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