Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Interventional Spine, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
248 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K160464 | Opticage(R) Expandable Interbody Fusion Device | Interventional Spine, Inc. | 2016-04-04 | 45 | 2 |
| K152156 | Opticage Expandable Interbody Fusion Device | Interventional Spine, Inc. | 2015-10-19 | 77 | 2 |
| K140716 | OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE | Interventional Spine, Inc. | 2014-11-24 | 248 | 0 |
| K133583 | OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070 | Interventional Spine, Inc. | 2014-02-10 | 81 | 0 |
| K132479 | OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00 | Interventional Spine, Inc. | 2013-09-19 | 42 | 0 |
| K113527 | OPTICAGE INTERBODY FUSION DEVICE | Interventional Spine, Inc. | 2012-01-20 | 51 | 0 |
| K090767 | PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER | Interventional Spine, Inc. | 2009-06-11 | 80 | 0 |
| K082795 | SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT | Interventional Spine, Inc. | 2008-12-12 | 80 | 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