Wenzel Spine, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under 2 spellings of the applicant name “Wenzel Spine, Inc.” (first 2010, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 158 days. Since 2017 the median was 163 days, against 102 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 | 0 | — |
| 2013 | 2 | 228 |
| 2014 | 0 | — |
| 2015 | 1 | 154 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 304 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 111 |
| 2024 | 0 | — |
| 2025 | 1 | 163 |
| 2026 | 1 | 30 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Wenzel Spine, Inc. took a median 163 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 102 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 4 | 4 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 4 | 4 |
| OUR | Sacroiliac Joint Fixation | 1 | 1 |
| PEK | Spinous Process Plate | 1 | 1 |
Review panels
- Orthopedic (10)
Most recent Wenzel Spine, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262595 | VariLift-C Cervical Interbody Fusion System | ODP | 2026-08-26 | 30 |
| K250247 | panaSIa SI Fusion System | OUR | 2025-07-09 | 163 |
| K231076 | VariLift®-C Interbody Fusion System | ODP | 2023-09-27 | 166 |
| K231807 | primaLOK SP Interspinous Fusion System | PEK | 2023-08-15 | 56 |
| K180822 | VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System | MAX | 2019-01-28 | 304 |
| K151900 | VariLift-L Interbody Fusion Device | MAX | 2015-12-11 | 154 |
| K131296 | VARILIFT-L INTERBODY FUSION DEVICE | MAX | 2013-09-03 | 120 |
| K120603 | VARILIFT -C | ODP | 2013-01-29 | 336 |
| K111123 | VARILIFT CERVICAL INTERBODY FUSION SYSTEM | ODP | 2011-12-08 | 231 |
| K100820 | WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEM | MAX | 2010-08-05 | 135 |
Recalls
openFDA lists no recalls under a recalling firm named Wenzel Spine, Inc..
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.
Device clinical trials
An industry sponsor named Wenzel Spine, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01944345: Patient Registry to Observe Outcomes Following Implantation of the VariLift Interbody Fusion Device (Completed, started 2013-06)
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Wenzel Spine, Inc. (7)
- Wenzel Spine (3)
Frequently asked questions
How many FDA 510(k) clearances are listed under Wenzel Spine, Inc.?
FDA lists 10 510(k) clearances under 2 spellings of the applicant name “Wenzel Spine, Inc.” (first 2010, latest 2026), across 4 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 Wenzel Spine, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wenzel Spine, Inc. is 158 days. Since 2017: 163 days, versus 102 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Wenzel Spine, Inc.?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 4); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 4); OUR (Sacroiliac Joint Fixation, 1).
Next steps
- See all 10 Wenzel Spine, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MAX, Wenzel Spine, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.