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
VEO® Lateral Interbody Fusion System	21-0774	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-1412011	FDA UDI	Class I	Active
LANCER™ Pedicle Screw System	MC40-P090	FDA UDI	Class II	Active
Tigershark	P070-T360706	FDA UDI	Class II	Active
LANCER™/THUNDERBOLT™ Pedicle Screw System	M070-0074	FDA UDI	Class I	Active
Acapella One	05-099-10-0002	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-34250013	FDA UDI	Class I	Active
HAWKEYE™ Vertebral Body Replacement (VBR)	DP40-1416646	FDA UDI	Class II	Active
Ambassador Cervical Plate System	05-109-13-0000	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP50-42300614	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive and LANCER™ Open Pedicle Screw System	MT80-ULL96	FDA UDI	Class II	Active
Boomerang	BT10-0019	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	V070-0023	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	ET50-5065	FDA UDI	Class II	Active
THUNDERBOLT Minimally Invasive Pedicle Screw Systems	MT32-95110	FDA UDI	Class II	Active
Thunderbolt	MT11-9545-120	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	T070-32110	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	T070-25104	FDA UDI	Class I	Active
Tiger Shark System	P070-24076	FDA UDI	Class II	Active
Gibralt	05-009-12-2728	FDA UDI	Class I	Active
Choice Spine SPITFIRE Retractor	M070-1010	FDA UDI	Class I	Active
Tiger Shark Spinal System	P070-32176W	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	R070-0029	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	ET10-4555	FDA UDI	Class II	Active
HAWKEYE™ Vertebral Body Replacement (VBR)	DP40-1416012	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH30-1616011	FDA UDI	Class II	Active
Thunderbolt	MT11-5045-120	FDA UDI	Class II	Active
BLACKBIRD™ Spinal System	L070-0001	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP30-34250617	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	E070-0005	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	RH20-1412806	FDA UDI	Class II	Active
SHARK™ Lumbar Spacer System	PP10-20134	FDA UDI	Class II	Active
Ambassador	05-100-08-4013	FDA UDI	Class II	Active
Silverbolt/Mainframe	201-2260	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-6018	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	E070-0069	FDA UDI	Class I	Active
Ascendant	05-099-31-1606N	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-42300010	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	V070-0001	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP40-38270416	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	R070-1412709	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP10-26200618	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	E070-0035	FDA UDI	Class I	Active
LANCER™ Pedicle Screw System	MT40-H300	FDA UDI	Class II	Active
ORIA™ CLARIS Spinal Clip System	2T46-P100	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	22-0467-21	FDA UDI	Class II	Active
BLACKBIRD™ Spinal System	L070-0031	FDA UDI	Class I	Active
LANCER Pedicle Screw System	MT31-6545	FDA UDI	Class II	Active
SHARK™ Lumbar Spacer System	PP20-28160	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP40-38270812	FDA UDI	Class II	Active

Choicespine, LP

What Choicespine, LP makes

Frequently asked questions

Information

Catalogue (9808)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities