Ldr Spine USA: FDA filings under this applicant name
FDA lists 35 510(k) clearances under the applicant name “Ldr Spine USA” (first 2005, latest 2017), across 13 product codes in 1 review panel. Median 510(k) review time under this name: 119 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 135 |
| 2013 | 1 | 119 |
| 2014 | 1 | 126 |
| 2015 | 3 | 177 |
| 2016 | 4 | 135 |
| 2017 | 1 | 288 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ldr Spine USA took a median 288 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQP | Spinal Vertebral Body Replacement Device | 8 | 8 |
| MNI | Orthosis, Spinal Pedicle Fixation | 5 | 5 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 4 | 4 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 | 3 |
| NKB | Thoracolumbosacral Pedicle Screw System | 3 | 3 |
| MQV | Filler, Bone Void, Calcium Compound | 2 | 2 |
| MRW | System, Facet Screw Spinal Device | 2 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
Plus 3 more product codes.
Review panels
- Orthopedic (35)
Most recent Ldr Spine USA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162133 | VerteFIT Corpectomy Cage System | MQP | 2017-05-16 | 288 |
| K161173 | Avenue® T TLIF Cage | OVD | 2016-09-28 | 155 |
| K161798 | FacetBRIDGE® System | MRW | 2016-08-04 | 35 |
| K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System | MAX | 2016-03-31 | 115 |
| K152137 | FacetBRIDGE System | MRW | 2016-01-25 | 178 |
| K151934 | ROI-C Titanium-Coated Implant System | OVE | 2015-12-07 | 146 |
| K150765 | LDR Spine ROI-C Cervical Cage System | OVE | 2015-09-17 | 177 |
| K142645 | Avenue T TLIF Cage | OVD | 2015-06-11 | 267 |
| K133363 | INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM | PEK | 2014-03-07 | 126 |
| K123134 | EASYSPINE SYSTEM | NKB | 2013-02-01 | 119 |
25 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2016-08-29.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Ldr Spine USA is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03077516: Post-Market, Long-Term Follow Up of Mobi-C® Cervical Disc for One and Two Level Treatment of Cervical Disc Disease (Completed, started 2016-11)
- NCT02104141: Retrospective/Prospective Data Collection on the LDR ROIA Interbody Fusion Device With VerteBRIDGE Plating (Completed, started 2013-11)
- NCT02104167: Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating (Completed, started 2013-09)
- NCT00389597: LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE (Completed, started 2006-04)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ldr Spine USA?
FDA lists 35 510(k) clearances under the applicant name “Ldr Spine USA” (first 2005, latest 2017), across 13 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ldr Spine USA?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ldr Spine USA is 119 days.
Which FDA product codes appear under Ldr Spine USA?
The most frequent FDA product codes under this applicant name are MQP (Spinal Vertebral Body Replacement Device, 8); MNI (Orthosis, Spinal Pedicle Fixation, 5); OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar, 4).
Next steps
- See all 35 Ldr Spine USA clearances with predicates and recalls
- Run predicate analysis for product code MQP, Ldr Spine USA's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.