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
HARRIER™ Choice Spine Intervertebral Body Device	JP30-34250417	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP20-30220019	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	R070-Z010	FDA UDI	Class I	Active
BLACKHAWK Cervical Spacer System	05-099-01-3100	FDA UDI	Class II	Active
Thunderbolt	MT11-4530-120	FDA UDI	Class II	Active
Tiger Shark	P070-1017	FDA UDI	Class I	Active
Ambassador Cervical Plate System	05-109-09-0000	FDA UDI	Class I	Active
SHARK™ Lumbar Spacer System	PP20-28184	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH20-1412407	FDA UDI	Class II	Active
Tiger Shark System	S-VT12-45170015	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	SPCL-R1412805	FDA UDI	Class I	Active
THUNDERBOLT Minimally Invasive Pedicle Screw Systems	MT10-10535	FDA UDI	Class II	Active
Ambassador Cervical Plate System	05-109-18-0000	FDA UDI	Class I	Active
SHARK Lumbar Spacer System	PT22-22184	FDA UDI	Class II	Active
HARPOON™ Lumbar Spacer System	PP42-28174	FDA UDI	Class II	Active
Octane M	05-041-06-3007	FDA UDI	Class II	Active
Boomerang	B070-0003-A1	FDA UDI	Class I	Active
Gibralt	05-009-12-2726	FDA UDI	Class I	Active
HAWKEYE™ Vertebral Body Replacement (VBR)	DP30-1214623	FDA UDI	Class II	Active
Octane Straight	05-071-02-3211	FDA UDI	Class II	Active
Acapella One	05-090-01-1408	FDA UDI	Class II	Active
Proliant	05-050-00-4560	FDA UDI	Class II	Active
Silverbolt/Mainframe	200-2445	FDA UDI	Class II	Active
LANCER/THUNDERBOLT Pedicle Screw System	M070-0109	FDA UDI	Class I	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-CN1214611	FDA UDI	Class I	Active
Tiger Shark System	P070-32086	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH30-1614706	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	R070-N1614807	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	22-0467-04	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT40-S150	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	SPCL-R004	FDA UDI	Class I	Active
Thunderbolt	MT11-5525-120	FDA UDI	Class II	Active
BLACKHAWK Cervical Spacer System	05-099-01-4100	FDA UDI	Class II	Active
SHARK™ Lumbar Spacer System	PP22-22164	FDA UDI	Class I	Active
"Lumbar Spacer System (SABRE, SHARK, HORNET, HARPOON)"	P070-2105	FDA UDI	Class I	Active
BLACKBIRD™ Spinal System	L070-0023	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	T070-28080	FDA UDI	Class I	Active
Acapella One	05-099-06-1606	FDA UDI	Class I	Active
Ambassador Cervical Plate System	05-109-22-2520	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP50-42300411	FDA UDI	Class II	Active
Octane Straight PC	05-072-01-2415	FDA UDI	Class II	Active
Octane M	05-041-01-2611	FDA UDI	Class II	Active
STEALTH™ Anterior Cervical Interbody Spacer	DP10-1214606	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT30-7555	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET10-4525	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	22-0476-06	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET50-80110	FDA UDI	Class II	Active
HAWKEYE™ Vertebral Body Replacement (VBR)	DP40-1416028	FDA UDI	Class II	Active
HAWKEYE™ Vertebral Body Replacement (VBR)	DP30-1214631	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-28176	FDA UDI	Class II	Active

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