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
Octane Straight PC	05-072-01-2809	FDA UDI	Class II	Active
LANCER/THUNDERBOLT Pedicle Screw System	M070-0139	FDA UDI	Class I	Active
VEO Lateral Interbody Fusion System	VT10-55170007	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	Y070-26321013	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	SPCL-P048	FDA UDI	Class I	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-C1214609	FDA UDI	Class I	Active
TOMCAT Cervical Spinal System	R070-1004	FDA UDI	Class I	Active
HAWKEYE™ Vertebral Body Replacement (VBR)	DP30-1214047	FDA UDI	Class II	Active
Tiger Shark System	S-VT12-55220615	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH30-1614010	FDA UDI	Class II	Active
BLACKBIRD™ Spinal System	SPCL-L010	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-6026	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	22-0466-01	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	20-3006	FDA UDI	Class I	Active
Gibralt	05-000-20-3538	FDA UDI	Class II	Active
Proliant	05-052-10-0480	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-42300009	FDA UDI	Class I	Active
HAWKEYE™ Vertebral Body Replacement (VBR)	DP40-1416650	FDA UDI	Class II	Active
SHARK Lumbar Spacer System	PT22-22124	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP50-42300618	FDA UDI	Class II	Active
Ascendant	05-090-10-1808	FDA UDI	Class II	Active
Lancer & Thunderbolt Pedicle Screw System	M070-0148	FDA UDI	Class I	Active
Tiger Shark System	S-VT12-65170613	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	SPCL-PAA15	FDA UDI	Class I	Active
Silverbolt/Mainframe	202-2250	FDA UDI	Class II	Active
HAWKEYE™ Vertebral Body Replacement (VBR)	DP30-1214639	FDA UDI	Class II	Active
VEO Lateral Interbody Fusion System	VT10-55170609	FDA UDI	Class II	Active
Thunderbolt	MT11-5055-080	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	RH20-1412406	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT10-8590	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT10-4540	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT50-8535	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET50-5080	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET10-7030	FDA UDI	Class II	Active
TiGER SHARK Interbody Fusion System	D070-DS014120708	FDA UDI	Class II	Active
HydraLok	PS75050	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	21-0789	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	E070-0013	FDA UDI	Class I	Active
BLACKBIRD™ Spinal System	LT20-3530	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH30-1618508	FDA UDI	Class II	Active
BLACKBIRD Spinal System	LT11-4538	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	Y070-0008	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT40-S050	FDA UDI	Class II	Active
TYPHOON™Facet Screw Fixation System	K070-0019	FDA UDI	Class I	Active
LANCER™ Pedicle Screw System	MT30-8565	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT10-7570	FDA UDI	Class II	Active
Tiger Shark Spinal System	P070-24166W	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT10-8580	FDA UDI	Class II	Active
BLACKHAWK Cervical Spacer System	S-TT20-1412C07	FDA UDI	Class II	Active
Thunderbolt	MT11-8565-120	FDA UDI	Class II	Active

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