Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Titan Spine, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
53 daysmedian FDA review time
208 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyp | Titan Spine, Inc. | 2020-01-08 | 208 | 0 |
| K192054 | Endoskeleton TAS Plate | Titan Spine, Inc. | 2019-08-29 | 29 | 0 |
| K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS an | Titan Spine, Inc. | 2019-08-16 | 18 | 0 |
| K191565 | Endoskeleton TCS Interbody Fusion Device | Titan Spine, Inc. | 2019-08-06 | 54 | 0 |
| K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS | Titan Spine, Inc. | 2019-02-11 | 53 | 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