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
Thunderbolt	MT11-7030-120	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	Y070-26321517	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	S-YT10-28361519	FDA UDI	Class II	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-14160817	FDA UDI	Class II	Active
Acapella One	05-099-10-0000	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	SPCL-P015	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-22090S	FDA UDI	Class I	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-14160838	FDA UDI	Class II	Active
BLACKBIRD Spinal System	LT11-4532	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	SPCL-P077	FDA UDI	Class I	Active
Tiger Shark System	S-PT46-24136	FDA UDI	Class II	Active
Triton	Q070-0005	FDA UDI	Class I	Active
Blackbird HLS	LT50-D2406	FDA UDI	Class II	Active
VEO Lateral Interbody Fusion System	V070-0037	FDA UDI	Class I	Active
ORIA XENA® Top Clip System	C070-6000	FDA UDI	Class I	Active
BLACKBIRD™ Spinal System	LT10-0001	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	RH30-1618012	FDA UDI	Class II	Active
SCS CLARIS Spinal System	7T20-AL09	FDA UDI	Class II	Active
Ascendant	05-090-10-1811	FDA UDI	Class II	Active
TYPHOON™Facet Screw Fixation System	KT10-4525	FDA UDI	U	Active
Thunderbolt	MT11-10525-080	FDA UDI	Class II	Active
BLACKBIRD™ Spinal System	L070-0014	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	22-0469-15	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	RH30-1618408	FDA UDI	Class II	Active
LANCER™/THUNDERBOLT™ Pedicle Screw System	MC20-P155	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-38271219	FDA UDI	Class I	Active
Ambassador	05-100-08-4021	FDA UDI	Class II	Active
Harrier-Sa Lumbar Interbody System	Y070-0063	FDA UDI	Class I	Active
LANCER Pedicle Screw System	MT40-DP070	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-6530	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT20-S310	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP10-26200612	FDA UDI	Class II	Active
Tiger Shark System	S-VT12-60171213	FDA UDI	Class II	Active
Silverbolt/Mainframe	200-0296	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	22-0466-18	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	22-0469-29	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT10-9580	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	E070-0002	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	ET30-7040	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET10-8565	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-34250408	FDA UDI	Class I	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MC20-P120	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-8045	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT30-6565	FDA UDI	Class II	Active
Ascendant	05-090-12-1612	FDA UDI	Class II	Active
VEO Lateral Interbody Fusion System	V070-122213	FDA UDI	Class I	Active
Acapella One	05-099-32-1405	FDA UDI	Class I	Active
Oracle Expandable Reactor System	500-9350	FDA UDI	Class I	Active
ORIA™ Spinal Clip System	2T10-BD625	FDA UDI	Class II	Active
HAWKEYE™ Vertebral Body Replacement (VBR)	DP40-1416637	FDA UDI	Class II	Active

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