Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wenzel Spine, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
163 daysmedian FDA review time
304 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250247 | panaSIa SI Fusion System | Wenzel Spine, Inc. | 2025-07-09 | 163 | 0 |
| K231076 | VariLift®-C Interbody Fusion System | Wenzel Spine, Inc. | 2023-09-27 | 166 | 0 |
| K231807 | primaLOK™ SP Interspinous Fusion System | Wenzel Spine, Inc. | 2023-08-15 | 56 | 0 |
| K180822 | VariLift-LX Interbody Fusion System, VariLift-C Interbody Fu | Wenzel Spine, Inc. | 2019-01-28 | 304 | 0 |
| K151900 | VariLift-L Interbody Fusion Device | Wenzel Spine, Inc. | 2015-12-11 | 154 | 0 |
| K131296 | VARILIFT-L INTERBODY FUSION DEVICE | Wenzel Spine, Inc. | 2013-09-03 | 120 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda