Renovis Surgical Technologies, LLC: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Renovis Surgical Technologies, LLC” (first 2010, latest 2019), across 14 product codes in 1 review panel. Median 510(k) review time under this name: 133 days. Since 2017 the median was 134 days, against 97 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 283 |
| 2013 | 3 | 149 |
| 2014 | 5 | 98 |
| 2015 | 3 | 98 |
| 2016 | 1 | 128 |
| 2017 | 2 | 154 |
| 2018 | 3 | 108 |
| 2019 | 1 | 146 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Renovis Surgical Technologies, LLC took a median 134 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 97 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 5 | 5 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 | 3 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | 3 | 3 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | 2 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 | 1 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 | 1 |
Plus 4 more product codes.
Review panels
- Orthopedic (23)
Most recent Renovis Surgical Technologies, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190122 | Renovis A200 PS Knee System as part of the Renovis A200 Knee System | JWH | 2019-06-20 | 146 |
| K182007 | Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System | OVD | 2018-12-07 | 133 |
| K181655 | Renovis S180 Lateral Lumbar Interbody Fusion System | MAX | 2018-09-11 | 81 |
| K180502 | S128 Anterior Lumbar Interbody Fusion (ALIF) System | OVD | 2018-06-14 | 108 |
| K171543 | Renovis Surgical Hip Replacement System | OQG | 2017-11-16 | 174 |
| K170888 | Renovis S141 Lumbar Interbody Fusion System | MAX | 2017-08-08 | 134 |
| K153250 | Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System | OVE | 2016-03-16 | 128 |
| K152193 | Renovis Anterior Cervical Plate System | KWQ | 2015-09-25 | 51 |
| K143647 | Renovis Surgical Hip Replacement System | OQG | 2015-05-11 | 140 |
| K143126 | Renovis S141 Lumbar Interbody Cage System | MAX | 2015-02-06 | 98 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Renovis Surgical Technologies, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Renovis Surgical Technologies, LLC?
FDA lists 23 510(k) clearances under the applicant name “Renovis Surgical Technologies, LLC” (first 2010, latest 2019), across 14 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Renovis Surgical Technologies, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Renovis Surgical Technologies, LLC is 133 days. Since 2017: 134 days, versus 97 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Renovis Surgical Technologies, LLC?
The most frequent FDA product codes under this applicant name are OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar, 5); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 3); OQG (Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented, 3).
Next steps
- See all 23 Renovis Surgical Technologies, LLC clearances with predicates and recalls
- Run predicate analysis for product code OVD, Renovis Surgical Technologies, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.