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
ORIA Zenith® Cervical Plate System	FT20-E227	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT30-7550	FDA UDI	Class II	Active
Ascendant	05-090-12-1810	FDA UDI	Class II	Active
Gibralt	05-000-26-3534	FDA UDI	Class II	Active
Gibralt	05-000-20-3514	FDA UDI	Class II	Active
Silverbolt/Mainframe	202-2235	FDA UDI	Class II	Active
Classic ACP	27401-130	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	T070-32104	FDA UDI	Class I	Active
Dynabolt	300-4260	FDA UDI	Class II	Active
HAWKEYE™ Vertebral Body Replacement (VBR)	DP30-1214642	FDA UDI	Class II	Active
Proliant	05-052-11-0090	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET50-7575	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET50-4580	FDA UDI	Class II	Active
Tiger Shark	P070-50130612	FDA UDI	Class I	Active
Lancer	M070-0162	FDA UDI	Class I	Active
Ambassador	05-100-09-4514	FDA UDI	Class II	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-N1214011	FDA UDI	Class I	Active
Ascendant	05-099-31-1412N	FDA UDI	Class I	Active
Tiger Shark System	S-PT34-28136	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP50-42300012	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP20-30220818	FDA UDI	Class II	Active
Ambassador Cervical Plate System	05-109-02-2004	FDA UDI	Class I	Active
LANCER Pedicle Screw System	MT40-DP090	FDA UDI	Class II	Active
BLACKBIRD Spinal System	LT15-3516	FDA UDI	Class II	Active
Octane Straight IR	PT23-32116	FDA UDI	Class I	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT20-P110	FDA UDI	Class II	Active
Thunderbolt	MT11-5535-080	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP15-26202012	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	R070-1412512	FDA UDI	Class I	Active
BLACKBIRD™ Spinal System	LT20-4026	FDA UDI	Class II	Active
SHARK™ Lumbar Spacer System	PP22-22094	FDA UDI	Class II	Active
ORIA XENA® Top Clip System	CT10-BP450	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT60-4580	FDA UDI	Class II	Active
HORNET™Lumbar Spacer System	PP30-25080	FDA UDI	Class II	Active
Octane M	05-041-02-3015	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP30-34250410	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP40-38270610	FDA UDI	Class II	Active
ORIA Zenith® Cervical Plate System	FT20-E339	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P072-22084	FDA UDI	Class I	Active
HARRIER-SA Lumbar Interbody System	S-YT10-26321019	FDA UDI	Class II	Active
Ascendant	05-099-31-1407N	FDA UDI	Class I	Active
Octane Straight	05-071-01-2814	FDA UDI	Class II	Active
SHARK Lumbar Spacer System	PT22-28144	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP50-42300417	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP30-34250614	FDA UDI	Class II	Active
BLACKBIRD Spinal System	LT11-4516	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P073-28114	FDA UDI	Class I	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-14160823	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP50-42301211	FDA UDI	Class II	Active
HORNET™Lumbar Spacer System	PP30-30170	FDA UDI	Class II	Active

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