Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Wenzel Spine with 10 510(k) clearances. The most recent is a 510(k) clearance dated Aug 26, 2026: VariLift-C Cervical Interbody Fusion System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 26, 2026 | VariLift-C Cervical Interbody Fusion SystemK262595 · ODP | 510(k) clearances |
| Jul 9, 2025 | panaSIa SI Fusion SystemK250247 · OUR | 510(k) clearances |
| Sep 27, 2023 | VariLift®-C Interbody Fusion SystemK231076 · ODP | 510(k) clearances |
| Aug 15, 2023 | primaLOK™ SP Interspinous Fusion SystemK231807 · PEK | 510(k) clearances |
| Jan 28, 2019 | VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemK180822 · MAX | 510(k) clearances |
| Dec 11, 2015 | VariLift-L Interbody Fusion DeviceK151900 · MAX | 510(k) clearances |
| Sep 3, 2013 | VARILIFT-L INTERBODY FUSION DEVICEK131296 · MAX | 510(k) clearances |
| Jan 29, 2013 | VARILIFT -CK120603 · ODP | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built