Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spinevision S.A. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
173 daysmedian FDA review time
274 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153783 | SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF | Spinevision S.A. | 2016-05-04 | 125 | 0 |
| K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Ped | Spinevision S.A. | 2016-04-04 | 75 | 0 |
| K133575 | SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, | Spinevision S.A. | 2014-06-30 | 222 | 0 |
| K130302 | SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATIO | Spinevision S.A. | 2013-07-30 | 173 | 0 |
| K112607 | SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIX | Spinevision S.A. | 2012-06-07 | 274 | 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