Ldr Spine USA
Austin, TX, US
Ldr Spine USA appears in FDA device records in Austin, TX. FDA records list 35 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 35 510(k) clearances for Ldr Spine USA between 2005 and 2017. The busiest year on record is 2005, with 4. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 4 |
| 2006 | 2 |
| 2007 | 3 |
| 2008 | 4 |
| 2009 | 4 |
| 2010 | 3 |
| 2011 | 2 |
| 2012 | 3 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 3 |
| 2016 | 4 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K162133 | VerteFIT Corpectomy Cage System | MQP | Substantially Equivalent | |
| K161173 | Avenue® T TLIF Cage | OVD | Substantially Equivalent | |
| K161798 | FacetBRIDGE® System | MRW | Substantially Equivalent | |
| K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System | MAX | Substantially Equivalent | |
| K152137 | FacetBRIDGE System | MRW | Substantially Equivalent | |
| K151934 | ROI-C Titanium-Coated Implant System | OVE | Substantially Equivalent | |
| K150765 | LDR Spine ROI-C Cervical Cage System | OVE | Substantially Equivalent | |
| K142645 | Avenue T TLIF Cage | OVD | Substantially Equivalent | |
| K133363 | INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM | PEK | Substantially Equivalent | |
| K123134 | EASYSPINE SYSTEM | NKB | Substantially Equivalent | |
| K121103 | LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S | NKB | Substantially Equivalent | |
| K113285 | LDR SPINE USA AVENUE L INTERBODY FUSION | OVD | Substantially Equivalent | |
| K120760 | LDR SPINE SPINETUNE TL SPINAL SYSTEM | MNH | Substantially Equivalent | |
| K113559 | LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS | ODP | Substantially Equivalent | |
| K110327 | LDR SPINE ROI-A INTERBODY FUSION SYSTEM | OVD | Substantially Equivalent | |
| K102331 | LDR SPINE USA SPINETUNE TL SPINAL SYSTEM | MNI | Substantially Equivalent | |
| K102265 | LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K100575 | LDR SPINE USA SPINE TUNE TL SPINE SYSTEM | MNI | Substantially Equivalent | |
| K091088 | LDR SPINE CERVICAL INTERBODY FUSION SYSTEM | ODP | Substantially Equivalent | |
| K090507 | MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM | MAX | Substantially Equivalent | |
| K083857 | LDR SPINE ROI-C IMPLANT | MQP | Substantially Equivalent | |
| K082262 | LDR SPINE ROI INTERBODY FUSION SYSTEM | MAX | Substantially Equivalent | |
| K082592 | LDR SPINE EASYSPINE SYSTEM | NKB | Substantially Equivalent | |
| K080728 | LDR SPINE ROI-C IMPLANT | MQP | Substantially Equivalent | |
| K080569 | LDR SPINE ROI-T IMPLANT | MQP | Substantially Equivalent | |
| K080572 | LDR SPINE ROI-A IMPLANT | MQP | Substantially Equivalent | |
| K072132 | LDR SPINE ROI-T SYSTEM | MQP | Substantially Equivalent | |
| K070341 | LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM | KWP | Substantially Equivalent | |
| K063794 | MODIFICATION TO EASYSPINE SYSTEM | MNI | Substantially Equivalent | |
| K061462 | BF+ (PH) | MQV | Substantially Equivalent | |
| K061017 | EASYSPINE SYSTEM | MNI | Substantially Equivalent | |
| K043479 | MC+ PARTIAL VBR | MQP | Substantially Equivalent | |
| K043349 | OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI) | MQP | Substantially Equivalent | |
| K043094 | EASYSPINE SYSTEM | MNI | Substantially Equivalent | |
| K043347 | BF+ | MQV | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- MQVFiller, Bone Void, Calcium Compound
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- MQPSpinal Vertebral Body Replacement Device
- PEKSpinous Process Plate
- MRWSystem, Facet Screw Spinal Device
- NKBThoracolumbosacral Pedicle Screw System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0045-2017 | ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device. | The ROI-A Anterior Delivery Device T-Handle, part number SI-ROIA-0023 has experienced binding of the rotation of the t-handle. There have been no reports of patient injury | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain