Choicespine, LP

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
26
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K190227Boomerang™ Anterior Cervical Plate SystemMay 1, 2019
K183397ChoiceSpine Stealth Cervical Spacer SystemMarch 6, 2019
K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemFebruary 22, 2019
K182721Choice Spine Navigation SystemJanuary 8, 2019
K183214Raven Lumbar Plate SystemJanuary 3, 2019
K180519HARRIER-SA™ Lumbar Interbody SystemMay 16, 2018
K172816TiGer Shark™ SystemJanuary 26, 2018
K173215Choice Spine Laminoplasty™ Fixation SystemJanuary 19, 2018
K171489Acapella Cervical Spacer SystemOctober 23, 2017
K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemSeptember 15, 2017
K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsAugust 3, 2017
K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemJune 8, 2017
K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsApril 26, 2017
K170953Tomcat Cervical Spinal SystemApril 21, 2017
K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody FusionNovember 23, 2016
K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsJune 3, 2016
K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral AccMay 19, 2016
K152515TOMCAT Cervical Spinal SystemDecember 18, 2015
K132049THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMSAugust 15, 2014
K140142CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON)July 16, 2014