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
TOMCAT Cervical Spinal System	S-RH20-1412006	FDA UDI	Class II	Active
Oracle Expandable Reactor System	500-9012	FDA UDI	Class I	Active
LANCER™/THUNDERBOLT™ Pedicle Screw System	SPCL-M005	FDA UDI	Class I	Active
HARRIER-SA Lumbar Interbody System	Y070-0014	FDA UDI	Class I	Active
BLACKBIRD Spinal System	LT11-3518	FDA UDI	Class II	Active
THUNDERBOLT Minimally Invasive Pedicle Screw Systems	MT10-11590	FDA UDI	Class II	Active
Thunderbolt	MT11-6075-120	FDA UDI	Class II	Active
LANCER Pedicle Screw System	MT30-105110	FDA UDI	Class II	Active
VEO Lateral Interbody Fusion System	VT10-50170608	FDA UDI	Class II	Active
HORNET™Lumbar Spacer System	PP30-30160	FDA UDI	Class II	Active
SHARK™ Lumbar Spacer System	PP22-22170	FDA UDI	Class II	Active
Ambassador	05-100-02-0036	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-4590	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET10-6535	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P072-22100	FDA UDI	Class I	Active
LANCER™ Pedicle Screw System	MT60-4570	FDA UDI	Class II	Active
SHARK™ Lumbar Spacer System	PP20-28080	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	RT10-T3510	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP50-42301214	FDA UDI	Class II	Active
ORIA XENA® Top Clip System	CT10-BP545	FDA UDI	Class II	Active
Octane A	602-98-1411	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-20126	FDA UDI	Class II	Active
Tiger Shark System	P070-2409096	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-N1412007	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	E070-0049	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP10-26200611	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET50-5045	FDA UDI	Class II	Active
SCS CLARIS Spinal Screws	2T10E7-55	FDA UDI	Class II	Active
Octane T	600-9135	FDA UDI	Class I	Active
Choice Spine SPITFIRE Retractor	M070-1008	FDA UDI	Class I	Active
TOMCAT Cervical Spinal System	S-RH30-1412710	FDA UDI	Class II	Active
Proliant	05-052-01-0090	FDA UDI	Class II	Active
VEO Lateral Interbody Fusion System	VT10-60170617	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET10-8545	FDA UDI	Class II	Active
Gibralt	05-009-12-2716	FDA UDI	Class I	Active
VEO Lateral Interbody Fusion System	VT10-40170609	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	T070-32124	FDA UDI	Class I	Active
Gibralt	05-009-45-0000	FDA UDI	Class I	Active
Thunderbolt	MT11-6580-080	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	T070-28114	FDA UDI	Class I	Active
Ascendant	05-090-12-1611	FDA UDI	Class II	Active
Octane Straight	05-071-01-2412	FDA UDI	Class II	Active
TIGER SHARK Spinal System	V070-1003L	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH20-1618706	FDA UDI	Class II	Active
THUNDERBOLT Minimally Invasive Pedicle Screw Systems	MT10-11560	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-20110	FDA UDI	Class II	Active
Tiger Shark System	S-PT47-36096	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT60-6530	FDA UDI	Class II	Active
THUNDERBOLT MI and LANCER Pedicle Screw System	MT40-DD10	FDA UDI	Class II	Active
FALCON™ Anterior Cervical Plate	A070-0D10	FDA UDI	Class I	Active

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