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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K140142

CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON) · Choicespine, LP · decided 2014-07-16 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
HARPOON™ Lumbar Spacer SystemPP42-28100Choice Spine, LPMAX MQP00840996118880
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)P072-25104Choice Spine, LPLXH00840996137973
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)P072-25144Choice Spine, LPLXH00840996138055
SHARK™ Lumbar Spacer SystemPP22-22084Choice Spine, LPMAX MPQ00840996128018
SHARK™ Lumbar Spacer SystemPP22-28110Choice Spine, LPMAX MQP00840996117036
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)P073-25094Choice Spine, LPLXH00840996138437
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)P073-25160Choice Spine, LPLXH00840996138567
HARPOON™ Lumbar Spacer SystemPP42-25084Choice Spine, LPMAX MQP00840996118613
SHARK™ Lumbar Spacer SystemPP22-22110Choice Spine, LPMAX MQP00840996116794
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)P073-28090Choice Spine, LPLXH00840996138666
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)P072-28170Choice Spine, LPLXH00840996138345
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)P072-28104Choice Spine, LPLXH00840996138215
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)P072-25130Choice Spine, LPLXH00840996138024
SHARK™ Lumbar Spacer SystemPP22-22174Choice Spine, LPMAX MPQ00840996128889
SHARK™ Lumbar Spacer SystemPP22-28080Choice Spine, LPMAX MQP00840996117005
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)P073-25124Choice Spine, LPLXH00840996138499
HARPOON™ Lumbar Spacer SystemPP42-28140Choice Spine, LPMAX MQP00840996118965
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)P072-28110Choice Spine, LPLXH00840996138222
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)P073-28134Choice Spine, LPLXH00840996138758
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)P072-22124Choice Spine, LPLXH00840996137775
HARPOON™ Lumbar Spacer SystemPP42-25124Choice Spine, LPMAX MQP00840996118699
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)P072-28144Choice Spine, LPLXH00840996138291
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)P072-22164Choice Spine, LPLXH00840996137850
SHARK™ Lumbar Spacer SystemPP22-28094Choice Spine, LPMAX MPQ00840996129046
HARPOON™ Lumbar Spacer SystemPP42-28130Choice Spine, LPMAX MQP00840996118941