Atlas FDA

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

Renovis Surgical Technologies, LLC — Predicate Candidate Screening

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

175 daysmedian FDA review time
406 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K132312RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SRenovis Surgical Technologies, LLC2014-04-112600
K131354RENOVIS BIPOLAR HIP SYSTEMRenovis Surgical Technologies, LLC2013-09-191320
K131122S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEMRenovis Surgical Technologies, LLC2013-09-181490
K120038A200 KNEE SYSTEMRenovis Surgical Technologies, LLC2013-02-144060
K112897RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESISRenovis Surgical Technologies, LLC2012-06-132540
K111940S 100 PEDICLE SCREW SYSTEMRenovis Surgical Technologies, LLC2012-05-153120
K113084RENOVIS CANNULATED SCREW SYSTEMRenovis Surgical Technologies, LLC2011-12-09520
K110965RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEMRenovis Surgical Technologies, LLC2011-05-11350
K101682S 100 PEDICLE SCREW SYSTEMRenovis Surgical Technologies, LLC2010-12-071750

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