Ldr Spine USA - FDA 510(k) Cleared Devices
Recent clearances: Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System, FacetBRIDGE System, ROI-C Titanium-Coated Implant System
25
Total
25
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ldr Spine USA Orthopedic ✕
25 devices
Cleared
Mar 31, 2016
Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage...
Orthopedic
115d
Cleared
Jan 25, 2016
FacetBRIDGE System
Orthopedic
178d
Cleared
Dec 07, 2015
ROI-C Titanium-Coated Implant System
Orthopedic
146d
Cleared
Sep 17, 2015
LDR Spine ROI-C Cervical Cage System
Orthopedic
177d
Cleared
Sep 30, 2011
LDR SPINE ROI-A INTERBODY FUSION SYSTEM
Orthopedic
239d
Cleared
Oct 15, 2010
LDR SPINE USA SPINETUNE TL SPINAL SYSTEM
Orthopedic
59d
Cleared
Sep 29, 2010
LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM
Orthopedic
50d
Cleared
Mar 31, 2010
LDR SPINE USA SPINE TUNE TL SPINE SYSTEM
Orthopedic
30d
Cleared
Jul 14, 2009
LDR SPINE CERVICAL INTERBODY FUSION SYSTEM
Orthopedic
90d
Cleared
Jun 25, 2009
MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM
Orthopedic
120d
Cleared
Feb 12, 2009
LDR SPINE ROI-C IMPLANT
Orthopedic
50d
Cleared
Feb 02, 2009
LDR SPINE ROI INTERBODY FUSION SYSTEM
Orthopedic
178d