LDR Spine USA, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
35
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0045-2017Class IIROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 August 29, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K162133VerteFIT Corpectomy Cage SystemMay 16, 2017
K161173Avenue® T TLIF CageSeptember 28, 2016
K161798FacetBRIDGE® SystemAugust 4, 2016
K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant SysteMarch 31, 2016
K152137FacetBRIDGE SystemJanuary 25, 2016
K151934ROI-C Titanium-Coated Implant SystemDecember 7, 2015
K150765LDR Spine ROI-C Cervical Cage SystemSeptember 17, 2015
K142645Avenue T TLIF CageJune 11, 2015
K133363INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEMMarch 7, 2014
K123134EASYSPINE SYSTEMFebruary 1, 2013
K121103LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPAugust 24, 2012
K113285LDR SPINE USA AVENUE L INTERBODY FUSIONJuly 26, 2012
K120760LDR SPINE SPINETUNE TL SPINAL SYSTEMJune 27, 2012
K113559LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTSDecember 29, 2011
K110327LDR SPINE ROI-A INTERBODY FUSION SYSTEMSeptember 30, 2011
K102331LDR SPINE USA SPINETUNE TL SPINAL SYSTEMOctober 15, 2010
K102265LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEMSeptember 29, 2010
K100575LDR SPINE USA SPINE TUNE TL SPINE SYSTEMMarch 31, 2010
K091088LDR SPINE CERVICAL INTERBODY FUSION SYSTEMJuly 14, 2009
K090507MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEMJune 25, 2009