Renovis Surgical Technologies, LLC
Round Rock, TX, US
Renovis Surgical Technologies, LLC appears in FDA device records in Round Rock, TX. FDA records list 23 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 23
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 23 510(k) clearances for Renovis Surgical Technologies, LLC between 2010 and 2019. The busiest year on record is 2014, with 5. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 2 |
| 2013 | 3 |
| 2014 | 5 |
| 2015 | 3 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 3 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K190122 | Renovis A200 PS Knee System as part of the Renovis A200 Knee System | JWH | Substantially Equivalent | |
| K182007 | Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System | OVD | Substantially Equivalent | |
| K181655 | Renovis S180 Lateral Lumbar Interbody Fusion System | MAX | Substantially Equivalent | |
| K180502 | S128 Anterior Lumbar Interbody Fusion (ALIF) System | OVD | Substantially Equivalent | |
| K171543 | Renovis Surgical Hip Replacement System | OQG | Substantially Equivalent | |
| K170888 | Renovis S141 Lumbar Interbody Fusion System | MAX | Substantially Equivalent | |
| K153250 | Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System | OVE | Substantially Equivalent | |
| K152193 | Renovis Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K143647 | Renovis Surgical Hip Replacement System | OQG | Substantially Equivalent | |
| K143126 | Renovis S141 Lumbar Interbody Cage System | MAX | Substantially Equivalent | |
| K141676 | RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM | LPH | Substantially Equivalent | |
| K142095 | RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM | OVD | Substantially Equivalent | |
| K141370 | RENOVIS CEMENTED HIP SYSTEM | JDI | Substantially Equivalent | |
| K132312 | RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM | LPH | Substantially Equivalent | |
| K140106 | S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM | OVD | Substantially Equivalent | |
| K131354 | RENOVIS BIPOLAR HIP SYSTEM | KWY | Substantially Equivalent | |
| K131122 | S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM | OVD | Substantially Equivalent | |
| K120038 | A200 KNEE SYSTEM | OIY | Substantially Equivalent | |
| K112897 | RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS | OQG | Substantially Equivalent | |
| K111940 | S 100 PEDICLE SCREW SYSTEM | MNH | Substantially Equivalent | |
| K113084 | RENOVIS CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | |
| K110965 | RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM | KTT | Substantially Equivalent | |
| K101682 | S 100 PEDICLE SCREW SYSTEM | MNI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KWQAppliance, Fixation, Spinal Intervertebral Body
- OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HWCScrew, Fixation, Bone
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain