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Renovis Surgical Technologies, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
23
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemJune 20, 2019
K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemDecember 7, 2018
K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemSeptember 11, 2018
K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemJune 14, 2018
K171543Renovis Surgical Hip Replacement SystemNovember 16, 2017
K170888Renovis S141 Lumbar Interbody Fusion SystemAugust 8, 2017
K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemMarch 16, 2016
K152193Renovis Anterior Cervical Plate SystemSeptember 25, 2015
K143647Renovis Surgical Hip Replacement SystemMay 11, 2015
K143126Renovis S141 Lumbar Interbody Cage SystemFebruary 6, 2015
K141676RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEMNovember 4, 2014
K142095RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEMOctober 15, 2014
K141370RENOVIS CEMENTED HIP SYSTEMSeptember 2, 2014
K132312RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEMApril 11, 2014
K140106S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEMMarch 27, 2014
K131354RENOVIS BIPOLAR HIP SYSTEMSeptember 19, 2013
K131122S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEMSeptember 18, 2013
K120038A200 KNEE SYSTEMFebruary 14, 2013
K112897RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESISJune 13, 2012
K111940S 100 PEDICLE SCREW SYSTEMMay 15, 2012