Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ldr Spine USA · Predicate Candidate Screening
25 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
94 daysmedian FDA review time
203 days90th percentile
25clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI | Ldr Spine USA | 2016-03-31 | 115 | 1 |
| K152137 | FacetBRIDGE System | Ldr Spine USA | 2016-01-25 | 178 | 0 |
| K151934 | ROI-C Titanium-Coated Implant System | Ldr Spine USA | 2015-12-07 | 146 | 0 |
| K150765 | LDR Spine ROI-C Cervical Cage System | Ldr Spine USA | 2015-09-17 | 177 | 0 |
| K110327 | LDR SPINE ROI-A INTERBODY FUSION SYSTEM | Ldr Spine USA | 2011-09-30 | 239 | 0 |
| K102331 | LDR SPINE USA SPINETUNE TL SPINAL SYSTEM | Ldr Spine USA | 2010-10-15 | 59 | 0 |
| K102265 | LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM | Ldr Spine USA | 2010-09-29 | 50 | 0 |
| K100575 | LDR SPINE USA SPINE TUNE TL SPINE SYSTEM | Ldr Spine USA | 2010-03-31 | 30 | 0 |
| K091088 | LDR SPINE CERVICAL INTERBODY FUSION SYSTEM | Ldr Spine USA | 2009-07-14 | 90 | 0 |
| K090507 | MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A | Ldr Spine USA | 2009-06-25 | 120 | 1 |
| K083857 | LDR SPINE ROI-C IMPLANT | Ldr Spine USA | 2009-02-12 | 50 | 0 |
| K082262 | LDR SPINE ROI INTERBODY FUSION SYSTEM | Ldr Spine USA | 2009-02-02 | 178 | 1 |
| K082592 | LDR SPINE EASYSPINE SYSTEM | Ldr Spine USA | 2008-10-08 | 30 | 0 |
| K080728 | LDR SPINE ROI-C IMPLANT | Ldr Spine USA | 2008-05-29 | 76 | 0 |
| K080569 | LDR SPINE ROI-T IMPLANT | Ldr Spine USA | 2008-05-07 | 68 | 0 |
| K080572 | LDR SPINE ROI-A IMPLANT | Ldr Spine USA | 2008-04-07 | 38 | 0 |
| K072132 | LDR SPINE ROI-T SYSTEM | Ldr Spine USA | 2007-08-30 | 28 | 0 |
| K070341 | LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM | Ldr Spine USA | 2007-08-08 | 183 | 0 |
| K063794 | MODIFICATION TO EASYSPINE SYSTEM | Ldr Spine USA | 2007-01-24 | 33 | 0 |
| K061462 | BF+ (PH) | Ldr Spine USA | 2006-12-15 | 203 | 0 |
| K061017 | EASYSPINE SYSTEM | Ldr Spine USA | 2006-08-10 | 119 | 0 |
| K043479 | MC+ PARTIAL VBR | Ldr Spine USA | 2005-06-30 | 196 | 0 |
| K043349 | OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI) | Ldr Spine USA | 2005-06-29 | 205 | 0 |
| K043094 | EASYSPINE SYSTEM | Ldr Spine USA | 2005-02-11 | 94 | 0 |
| K043347 | BF+ | Ldr Spine USA | 2005-01-07 | 32 | 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