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	RH20-1614807	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET50-6090	FDA UDI	Class II	Active
Tiger Shark System	P070-2809086	FDA UDI	Class I	Active
Oracle Expandable Reactor System	500-9601	FDA UDI	Class I	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT10-9535	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET50-5540	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-7045	FDA UDI	Class II	Active
Ambassador	05-100-07-4522	FDA UDI	Class II	Active
Ascendant	05-090-11-1606	FDA UDI	Class II	Active
SHARK™ Lumbar Spacer System	PP22-25174	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	ET30-8525	FDA UDI	Class II	Active
Octane Straight	05-071-03-2408	FDA UDI	Class II	Active
Gibralt	05-009-10-2018	FDA UDI	Class I	Active
VEO Lateral Interbody Fusion System	VT10-50220007	FDA UDI	Class II	Active
Octane T	600-9000	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	RH30-1614811	FDA UDI	Class II	Active
Tiger Shark System	S-PT46-28116	FDA UDI	Class II	Active
Proliant Posterior Pedicle Screw & Hook Fixation System	05-052-12-0080	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P073-25104	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	ET30-5525	FDA UDI	Class II	Active
Tiger Shark Spinal System	P070-32156W	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-34250409	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP20-30221212	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP10-26200809	FDA UDI	Class II	Active
BLACKBIRD Spinal System	LT21-4026	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET10-6075	FDA UDI	Class II	Active
VEO Lateral Interbody Fusion System	V070-01775P	FDA UDI	Class II	Active
FALCON™ Anterior Cervical Plate	FT10-BR412	FDA UDI	Class II	Active
ORIA Zenith® Cervical Plate System	F070-2020	FDA UDI	Class I	Active
Ambassador Cervical Plate System	05-109-22-2017	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	RH20-1616810	FDA UDI	Class II	Active
TYPHOON™Facet Screw Fixation System	KT20-5545	FDA UDI	U	Active
HARRIER-SA Lumbar Interbody System	S-YT60-28361513	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-20066	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	T070-25184	FDA UDI	Class I	Active
Ascendant PC	05-090-31-1812	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	20-3126	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	RH20-1614006	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET50-5590	FDA UDI	Class II	Active
BLACKBIRD™ Spinal System	LT30-C35602	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	R070-1614512	FDA UDI	Class I	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT50-6530	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-6025	FDA UDI	Class I	Active
HORNET™Lumbar Spacer System	PP30-30140	FDA UDI	Class II	Active
BLACKBIRD™ Spinal System	LT40-P070	FDA UDI	Class II	Active
Acapella One	05-099-07-1609	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP10-26201213	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	V070-A1715	FDA UDI	Class I	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-14160025	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT10-9565	FDA UDI	Class II	Active

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