LDR Spine USA, Inc.
FDA Regulatory Profile
LDR Spine USA, Inc. appears in FDA public data with 1 recall, 35 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0045-2017, Class II) was initiated on August 29, 2016. Its most recent 510(k) clearance was granted on May 16, 2017.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 35
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0045-2017 | Class II | ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 | August 29, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K162133 | VerteFIT Corpectomy Cage System | May 16, 2017 |
| K161173 | Avenue® T TLIF Cage | September 28, 2016 |
| K161798 | FacetBRIDGE® System | August 4, 2016 |
| K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant Syste | March 31, 2016 |
| K152137 | FacetBRIDGE System | January 25, 2016 |
| K151934 | ROI-C Titanium-Coated Implant System | December 7, 2015 |
| K150765 | LDR Spine ROI-C Cervical Cage System | September 17, 2015 |
| K142645 | Avenue T TLIF Cage | June 11, 2015 |
| K133363 | INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM | March 7, 2014 |
| K123134 | EASYSPINE SYSTEM | February 1, 2013 |
| K121103 | LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SP | August 24, 2012 |
| K113285 | LDR SPINE USA AVENUE L INTERBODY FUSION | July 26, 2012 |
| K120760 | LDR SPINE SPINETUNE TL SPINAL SYSTEM | June 27, 2012 |
| K113559 | LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS | December 29, 2011 |
| K110327 | LDR SPINE ROI-A INTERBODY FUSION SYSTEM | September 30, 2011 |
| K102331 | LDR SPINE USA SPINETUNE TL SPINAL SYSTEM | October 15, 2010 |
| K102265 | LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM | September 29, 2010 |
| K100575 | LDR SPINE USA SPINE TUNE TL SPINE SYSTEM | March 31, 2010 |
| K091088 | LDR SPINE CERVICAL INTERBODY FUSION SYSTEM | July 14, 2009 |
| K090507 | MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM | June 25, 2009 |