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
TYPHOON™Facet Screw Fixation System	K070-SD4423	FDA UDI	Class I	Active
SCS Spinal System	2T20-CL08	FDA UDI	Class II	Active
Octane Straight PC	05-072-04-2814	FDA UDI	Class II	Active
THUNDERBOLT Minimally Invasive Pedicle Screw Systems	MT10-10590	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	SPCL-P083	FDA UDI	Class I	Active
Thunderbolt	MT11-7025-080	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT50-95110	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET50-5565	FDA UDI	Class II	Active
Ascendant PC	05-090-32-1809	FDA UDI	Class II	Active
Gibralt	05-000-04-4030	FDA UDI	U	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT20-S330	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT10-4550	FDA UDI	Class II	Active
Thunderbolt	MT11-4545-080	FDA UDI	Class II	Active
Gibralt Spine System	05-009-94-0020	FDA UDI	Class I	Active
HARPOON™ Lumbar Spacer System	PP40-32144	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	V070-0101	FDA UDI	Class I	Active
Acapella One	05-099-33-1411	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP30-34250814	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT50-9535	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	R070-1412412	FDA UDI	Class I	Active
HAWKEYE™ Vertebral Body Replacement (VBR)	DP40-1416613	FDA UDI	Class II	Active
Octane T	05-049-01-0014	FDA UDI	Class I	Active
BLACKHAWK Cervical Spacer System	05-090-22-1406	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT50-5570	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	RH20-1616412	FDA UDI	Class II	Active
TYPHOON™Facet Screw Fixation System	KT20-4560	FDA UDI	U	Active
STARFIRE™ Pedicle Screw System	ET50-4535	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET50-7530	FDA UDI	Class II	Active
Octane Straight PC	05-072-01-2811	FDA UDI	Class II	Active
HAWKEYE™ Vertebral Body Replacement (VBR)	DP30-1214632	FDA UDI	Class II	Active
STEALTH™ Anterior Cervical Interbody Spacer	DP10-1214011	FDA UDI	Class II	Active
Ambassador Cervical Plate System	05-109-22-2316	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P072-25170	FDA UDI	Class I	Active
LANCER/THUNDERBOLT Pedicle Screw System	M070-LS112	FDA UDI	Class I	Active
BLACKHAWK Cervical Spacer System	05-099-02-4200	FDA UDI	Class II	Active
TYPHOON™Facet Screw Fixation System	K070-0013	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-N1412511	FDA UDI	Class I	Active
SHARK™ Lumbar Spacer System	PP20-32160	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MC20-S200	FDA UDI	Class II	Active
LANCER™/THUNDERBOLT™ Pedicle Screw System	M070-0032	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-1616010	FDA UDI	Class I	Active
ORIA XENA® Top Clip System	CT10-BP435	FDA UDI	Class II	Active
Octane A	602-98-1419	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-4540	FDA UDI	Class II	Active
Octane Straight PC	05-072-03-2814	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	Y070-28362017C	FDA UDI	Class II	Active
BLACKHAWK Cervical Spacer System	S-TT20-1614608	FDA UDI	Class II	Active
Tiger Shark System	P070-62414	FDA UDI	Class I	Active
Silverbolt/Mainframe	200-0270	FDA UDI	Class II	Active
Gibralt	05-000-20-3528	FDA UDI	Class II	Active

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