Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ldr Spine USA, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
135 daysmedian FDA review time
288 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162133 | VerteFIT Corpectomy Cage System | Ldr Spine USA, Inc. | 2017-05-16 | 288 | 0 |
| K161173 | Avenue® T TLIF Cage | Ldr Spine USA, Inc. | 2016-09-28 | 155 | 0 |
| K161798 | FacetBRIDGE® System | Ldr Spine USA, Inc. | 2016-08-04 | 35 | 0 |
| K142645 | Avenue T TLIF Cage | Ldr Spine USA, Inc. | 2015-06-11 | 267 | 0 |
| K133363 | INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM | Ldr Spine USA, Inc. | 2014-03-07 | 126 | 0 |
| K123134 | EASYSPINE SYSTEM | Ldr Spine USA, Inc. | 2013-02-01 | 119 | 0 |
| K121103 | LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EA | Ldr Spine USA, Inc. | 2012-08-24 | 135 | 0 |
| K113285 | LDR SPINE USA AVENUE L INTERBODY FUSION | Ldr Spine USA, Inc. | 2012-07-26 | 262 | 0 |
| K120760 | LDR SPINE SPINETUNE TL SPINAL SYSTEM | Ldr Spine USA, Inc. | 2012-06-27 | 106 | 0 |
| K113559 | LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IM | Ldr Spine USA, Inc. | 2011-12-29 | 28 | 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