Medical Device Manufacturer · US , Austin , TX

Ldr Spine USA - FDA 510(k) Cleared Devices

25 submissions · 25 cleared · Since 2005
25
Total
25
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ldr Spine USA Orthopedic ✕
25 devices
1-12 of 25
Cleared Mar 31, 2016
Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage...
K153495 · MAX
Orthopedic · 115d
Cleared Jan 25, 2016
FacetBRIDGE System
K152137 · MRW
Orthopedic · 178d
Cleared Dec 07, 2015
ROI-C Titanium-Coated Implant System
K151934 · OVE
Orthopedic · 146d
Cleared Sep 17, 2015
LDR Spine ROI-C Cervical Cage System
K150765 · OVE
Orthopedic · 177d
Cleared Sep 30, 2011
LDR SPINE ROI-A INTERBODY FUSION SYSTEM
K110327 · OVD
Orthopedic · 239d
Cleared Oct 15, 2010
LDR SPINE USA SPINETUNE TL SPINAL SYSTEM
K102331 · MNI
Orthopedic · 59d
Cleared Sep 29, 2010
LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM
K102265 · KWQ
Orthopedic · 50d
Cleared Mar 31, 2010
LDR SPINE USA SPINE TUNE TL SPINE SYSTEM
K100575 · MNI
Orthopedic · 30d
Cleared Jul 14, 2009
LDR SPINE CERVICAL INTERBODY FUSION SYSTEM
K091088 · ODP
Orthopedic · 90d
Cleared Jun 25, 2009
MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM
K090507 · MAX
Orthopedic · 120d
Cleared Feb 12, 2009
LDR SPINE ROI-C IMPLANT
K083857 · MQP
Orthopedic · 50d
Cleared Feb 02, 2009
LDR SPINE ROI INTERBODY FUSION SYSTEM
K082262 · MAX
Orthopedic · 178d
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