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
LANCER Pedicle Screw System	MT30-12545	FDA UDI	Class II	Active
VEO Lateral Interbody Fusion System	VT10-60220608	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	22-0467-14	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET50-55100	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	RH20-1614010	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET10-6065	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH20-1412406	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP40-38270611	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	YT30-5020	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-34250819	FDA UDI	Class I	Active
LANCER™/THUNDERBOLT™ Pedicle Screw System	M070-KN322	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	V070-0024	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	ET10-8525	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-4535	FDA UDI	Class II	Active
Gibralt	05-009-12-2724	FDA UDI	Class I	Active
ORIA™ Spinal Clip System	2T10-BD755	FDA UDI	Class II	Active
Dynabolt	300-4155	FDA UDI	Class II	Active
Thunderbolt	MT11-60100-120	FDA UDI	Class II	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-14160032	FDA UDI	Class II	Active
LANCER™/THUNDERBOLT™ Pedicle Screw System	M070-0010	FDA UDI	Class I	Active
Octane Straight	05-071-01-2413	FDA UDI	Class II	Active
Tiger Shark System	S-PT35-2808L	FDA UDI	Class II	Active
VEO Lateral Interbody Fusion System	V070-121715P	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	E070-0024	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	ET30-7555	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP20-30220810	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	T070-32164	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	ET30-6555	FDA UDI	Class II	Active
BLACKBIRD™ Spinal System	L070-0049	FDA UDI	Class I	Active
Navigation	NV70-Q007	FDA UDI	Class I	Active
BLACKHAWK Cervical Spacer System	S-TT20-1412006	FDA UDI	Class II	Active
Tiger Shark System	P070-28136	FDA UDI	Class II	Active
Gibralt	05-000-20-4034	FDA UDI	Class II	Active
Silverbolt/Mainframe Instruments	200-9255	FDA UDI	Class I	Active
BLACKBIRD Spinal System	LT25-4024	FDA UDI	Class II	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-C1214610	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	SPCL-P049	FDA UDI	Class I	Active
HARPOON™ Lumbar Spacer System	PP40-28144	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MC40-P030	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP30-34250611	FDA UDI	Class II	Active
Thunderbolt	MT11-5575-080	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	SPCL-P014	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-6021	FDA UDI	Class I	Active
LANCER Pedicle Screw System	MT30-7025	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-20160	FDA UDI	Class II	Active
FALCON™ Anterior Cervical Plate	SPCL-A021	FDA UDI	Class I	Active
Acapella One	05-099-27-1607	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	20-3476	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	V070-0109	FDA UDI	Class I	Active
TOMCAT Cervical Spinal System	S-RH20-1412408	FDA UDI	Class II	Active

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