Question 1

What types of medical devices does Choicespine, LP manufacture?

Accepted Answer

Choicespine, LP specializes in spinal fusion and fixation devices. Their portfolio includes polymeric and metallic interbody fusion cages designed to support the spine between vertebrae, non-bioabsorbable bone screws for internal spinal stabilization, and spinal fixation plates. They also produce systems for lateral interbody fusion and minimally invasive pedicle screw fixation, catering to procedures requiring precise spinal alignment and stability.

Question 2

Where is Choicespine, LP based, and what regulatory database lists its devices?

Accepted Answer

Choicespine, LP is based in the United States. Their devices are listed in the FDA’s Unique Device Identifier (UDI) database, which serves as a centralized registry for tracking medical devices authorized for use in the U.S. This database helps ensure transparency and traceability of devices like their spinal fusion cages and fixation systems.

Question 3

How are Choicespine, LP’s devices classified by the FDA?

Accepted Answer

Choicespine, LP’s devices fall under three FDA classification categories: Class I (generally low-risk devices), Class II (devices requiring special controls to ensure safety and effectiveness), and Unclassified (U), which includes devices still under review or awaiting classification. The classification depends on factors like the device’s intended use, risk level, and regulatory pathway, ensuring appropriate oversight for spinal fusion and fixation products.

Question 4

What kinds of spinal systems does Choicespine, LP offer, and how do they differ?

Accepted Answer

Choicespine, LP offers a range of spinal systems, including polymeric and metallic interbody fusion cages (e.g., VEO® Lateral Interbody Fusion System) for intervertebral support, minimally invasive pedicle screw systems (e.g., THUNDERBOLT™) for precise fixation, and cervical spinal systems (e.g., TOMCAT™) tailored for neck procedures. Their devices vary by material (e.g., non-bioabsorbable screws vs. sterile/non-sterile cages) and application, such as lateral access or traditional open surgery, to address specific spinal stability needs.

Device	Model / Reference	Registries	Class	Status
Tiger Shark System	S-PT34-24130	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	RH30-1616408	FDA UDI	Class II	Active
Tiger Shark System	S-PT46-32116	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J070-0042	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-2118	FDA UDI	Class I	Active
LANCER Pedicle Screw System	MT60-10555	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	T070-28164S	FDA UDI	Class I	Active
Gibralt	05-000-20-5550	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive and LANCER™ Open Pedicle Screw System	MT80-SLS60	FDA UDI	Class II	Active
HARPOON™ Lumbar Spacer System	PP40-32100	FDA UDI	Class II	Active
Acapella One	05-099-32-1604	FDA UDI	Class I	Active
Ambassador Cervical Plate System	05-109-10-0001	FDA UDI	Class I	Active
Acapella One	05-099-28-1810	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-42300021	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-1508	FDA UDI	Class I	Active
LANCER™/THUNDERBOLT™ Pedicle Screw System	M070-0088	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	SPCL-P018	FDA UDI	Class I	Active
HARRIER-SA Lumbar Interbody System	S-YP10-28363019	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP50-42300816	FDA UDI	Class II	Active
Octane P	601-98-0207	FDA UDI	Class II	Active
Thunderbolt	MT11-5035-080	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MC40-P080	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive and LANCER™ Open Pedicle Screw System	MT80-ELL96	FDA UDI	Class II	Active
TigerShark L	V070-1023	FDA UDI	Class I	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-14160829	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-32146	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-22160S	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP40-38270013	FDA UDI	Class II	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-14160011	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	RH20-1618412	FDA UDI	Class II	Active
Tiger Shark System	S-VT12-60170617	FDA UDI	Class II	Active
Thunderbolt	MT11-7570-080	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	Y070-28362517	FDA UDI	Class II	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-1416009	FDA UDI	Class I	Active
HARPOON™ Lumbar Spacer System	PP42-25154	FDA UDI	Class II	Active
FALCON™ Anterior Cervical Plate	AT10-3062	FDA UDI	Class II	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-14160813	FDA UDI	Class II	Active
HARPOON™ Lumbar Spacer System	PP40-32170	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MC20-S240	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	S-YP10-28363021	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MC20-P115	FDA UDI	Class II	Active
Thunderbolt	MT11-10580-120	FDA UDI	Class II	Active
SHARK Lumbar Spacer System	PT22-22144	FDA UDI	Class I	Active
Octane T	600-9150	FDA UDI	Class I	Active
Oracle Expandable Reactor System	500-9116	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	22-0555	FDA UDI	Class I	Active
HARPOON™ Lumbar Spacer System	PP40-32150	FDA UDI	Class II	Active
Ascendant	05-090-11-1610	FDA UDI	Class II	Active
BLACKBIRD™ Spinal System	LT10-3524	FDA UDI	Class II	Active
Ascendant PC	05-090-30-1610	FDA UDI	Class II	Active

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