FDA 510(k) Applications Submitted by LDR SPINE USA

FDA 510(k) Number Submission Date Device Name Applicant
K102265 08/10/2010 LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM LDR SPINE USA
K102331 08/17/2010 LDR SPINE USA SPINETUNE TL SPINAL SYSTEM LDR SPINE USA
K150765 03/24/2015 LDR Spine ROI-C Cervical Cage System LDR SPINE USA
K153495 12/07/2015 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System LDR Spine USA
K043349 12/06/2004 OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI) LDR SPINE USA
K043094 11/09/2004 EASYSPINE SYSTEM LDR SPINE USA
K043347 12/06/2004 BF+ LDR SPINE USA
K043479 12/16/2004 MC+ PARTIAL VBR LDR SPINE USA
K061017 04/13/2006 EASYSPINE SYSTEM LDR SPINE USA
K061462 05/26/2006 BF+ (PH) LDR SPINE USA
K063794 12/22/2006 MODIFICATION TO EASYSPINE SYSTEM LDR SPINE USA
K070341 02/06/2007 LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM LDR SPINE USA
K072132 08/02/2007 LDR SPINE ROI-T SYSTEM LDR SPINE USA
K151934 07/14/2015 ROI-C Titanium-Coated Implant System LDR SPINE USA
K152137 07/31/2015 FacetBRIDGE System LDR SPINE USA
K110327 02/03/2011 LDR SPINE ROI-A INTERBODY FUSION SYSTEM LDR SPINE USA
K090507 02/25/2009 MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM LDR SPINE USA
K080569 02/29/2008 LDR SPINE ROI-T IMPLANT LDR SPINE USA
K080572 02/29/2008 LDR SPINE ROI-A IMPLANT LDR SPINE USA
K100575 03/01/2010 LDR SPINE USA SPINE TUNE TL SPINE SYSTEM LDR SPINE USA
K080728 03/14/2008 LDR SPINE ROI-C IMPLANT LDR SPINE USA
K091088 04/15/2009 LDR SPINE CERVICAL INTERBODY FUSION SYSTEM LDR SPINE USA
K082592 09/08/2008 LDR SPINE EASYSPINE SYSTEM LDR SPINE USA
K083857 12/24/2008 LDR SPINE ROI-C IMPLANT LDR SPINE USA
K082262 08/08/2008 LDR SPINE ROI INTERBODY FUSION SYSTEM LDR SPINE USA


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