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
TOMCAT™ Cervical Spinal System	R070-N1412711	FDA UDI	Class I	Active
THUNDERBOLT Minimally Invasive Pedicle Screw Systems	MT32-105100	FDA UDI	Class II	Active
Octane T	600-1111	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP20-30220621	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	R070-1618012	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-N1412707	FDA UDI	Class I	Active
LANCER™/THUNDERBOLT™ Pedicle Screw System	M070-0026	FDA UDI	Class I	Active
Thunderbolt	MT11-5545-120	FDA UDI	Class II	Active
Tiger Shark System	P070-2809096	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP40-38271218	FDA UDI	Class II	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-0004	FDA UDI	Class I	Active
Thunderbolt	MT11-7565-080	FDA UDI	Class II	Active
Tiger Shark System	P070-3211126	FDA UDI	Class I	Active
HAWKEYE Vertebral Body Replacement (VBR)	D070-0011	FDA UDI	Class I	Active
Octane M	05-049-04-0000	FDA UDI	Class I	Active
Octane M	05-041-02-3014	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-8560	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET10-45110	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-5565	FDA UDI	Class II	Active
Gibralt	05-002-01-0001	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT30-7530	FDA UDI	Class II	Active
SHARK™ Lumbar Spacer System	PP20-32130	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	22-0660	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	21-0773	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-1412010	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-1618008	FDA UDI	Class I	Active
Harrier-SA Lumbar Interbody System	Y070-30401019C	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-42300410	FDA UDI	Class I	Active
Acapella One	05-099-11-0002	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	RH30-1412008	FDA UDI	Class II	Active
Ascendant PC	05-090-32-1607	FDA UDI	Class II	Active
Tiger Shark	P070-6133	FDA UDI	Class I	Active
BLACKBIRD Spinal System	LT25-4022	FDA UDI	Class II	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-14160048	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-2116	FDA UDI	Class I	Active
Octane A	602-98-1309	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	RH30-1614007	FDA UDI	Class II	Active
BLACKBIRD™ Spinal System	LT20-3520	FDA UDI	Class II	Active
HARPOON™ Lumbar Spacer System	PP40-28184	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET50-7040	FDA UDI	Class II	Active
Thunderbolt	MT11-5060-120	FDA UDI	Class II	Active
Tiger Shark Spinal System	P070-32186W	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH30-1412009	FDA UDI	Class II	Active
Ascendant	05-090-12-1607	FDA UDI	Class II	Active
Classic ACP	27401-359	FDA UDI	Class II	Active
FALCON™ Anterior Cervical Plate	AT10-2030	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P072-22070	FDA UDI	Class I	Active
Silverbolt/Mainframe	200-0480	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P073-25154	FDA UDI	Class I	Active
Ambassador	SK-014856-16	FDA UDI	Class I	Active

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