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-SD4430	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	RH20-1412409	FDA UDI	Class II	Active
Octane Straight PC	05-072-01-3215	FDA UDI	Class II	Active
Ascendant	05-090-11-1605	FDA UDI	Class II	Active
Tiger Shark System	S-PT47-25126	FDA UDI	Class II	Active
Ascendant	05-090-11-1604	FDA UDI	Class II	Active
Octane Straight	05-071-02-3215	FDA UDI	Class II	Active
Ascendant	05-090-12-1811	FDA UDI	Class II	Active
Silverbolt/Mainframe	200-0660	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET50-7590	FDA UDI	Class II	Active
Ascendant	05-090-10-1405	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT10-8535	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT50-9525	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-55110	FDA UDI	Class II	Active
Silverbolt/Mainframe	201-0290	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH20-1614812	FDA UDI	Class II	Active
STEALTH™ Anterior Cervical Interbody Spacer	DP10-1214605	FDA UDI	Class II	Active
Tiger Shark	P070-6115	FDA UDI	Class I	Active
TYPHOON™Facet Screw Fixation System	K070-SD4523	FDA UDI	Class I	Active
LANCER™ Pedicle Screw System	MT40-H060	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	22-0468-10	FDA UDI	Class II	Active
Thunderbolt	MT11-5550-120	FDA UDI	Class II	Active
Tiger Shark System	P070-2809106	FDA UDI	Class I	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-12140059	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-42300810	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-1618412	FDA UDI	Class I	Active
LANCER™ Pedicle Screw System	MC40-S040	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET10-7545	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT10-5555	FDA UDI	Class II	Active
Gibralt	05-009-36-3224	FDA UDI	Class I	Active
Acapella One	05-099-04-1401	FDA UDI	Class I	Active
Ascendant	05-090-12-1411	FDA UDI	Class II	Active
Tigershark	P070-T281012	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	Y070-26321517C	FDA UDI	Class II	Active
Tiger Shark System	S-VT12-65170011	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	SPCL-V006	FDA UDI	Class I	Active
FALCON™ Anterior Cervical Plate	A070-0T16	FDA UDI	Class I	Active
SHARK™ Lumbar Spacer System	PP22-28170	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT50-65110	FDA UDI	Class II	Active
LANCER™/THUNDERBOLT™ Pedicle Screw System	MC20-P135	FDA UDI	Class II	Active
Thunderbolt	MT11-6075-080	FDA UDI	Class II	Active
Raven	YT35-5560	FDA UDI	Class II	Active
LANCER/THUNDERBOLT Pedicle Screw System	M070-KTS324	FDA UDI	Class I	Active
Tiger Shark System	S-PT34-28090	FDA UDI	Class II	Active
Octane T	05-049-01-0013	FDA UDI	Class I	Active
Acapella One	05-099-14-0001	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	SPCL-P067	FDA UDI	Class I	Active
BLACKBIRD™ Spinal System	SPCL-L005	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	22-0466-08	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	S-YT60-26321017	FDA UDI	Class II	Active

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