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
Octane Straight PC	05-072-03-2414	FDA UDI	Class II	Active
Tiger Shark System	S-PT47-40086	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	22-0467-07	FDA UDI	Class II	Active
LANCER™/THUNDERBOLT™ Pedicle Screw System	M070-0060	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	E070-0048	FDA UDI	Class I	Active
SHARK™ Lumbar Spacer System	PP20-28134	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	RH30-1616808	FDA UDI	Class II	Active
Ambassador	05-100-07-4515	FDA UDI	Class II	Active
ORIA™ CLARIS Spinal Clip System	2T46-T030	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT30-6545	FDA UDI	Class II	Active
Octane Straight PC	05-072-04-2815	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	SPCL-P060	FDA UDI	Class I	Active
VEO Lateral Interbody Fusion System	VT10-55220608	FDA UDI	Class II	Active
Thunderbolt	MT11-7060-120	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	Y070-28363023	FDA UDI	Class II	Active
BLACKHAWK Cervical Spacer System	05-090-22-1610	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-28086	FDA UDI	Class II	Active
Octane Straight IR	PT23-36156	FDA UDI	Class I	Active
TOMCAT Cervical Spinal System	S-RH20-1412712	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P073-28160	FDA UDI	Class I	Active
Ambassador	05-100-05-0085	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT10-4590	FDA UDI	Class II	Active
HAWKEYE™ Vertebral Body Replacement (VBR)	DP40-1416035	FDA UDI	Class II	Active
Thunderbolt	MT11-65100-120	FDA UDI	Class II	Active
Raven Lumbar Plate System	Y070-1000	FDA UDI	Class I	Active
SHARK™ Lumbar Spacer System	PP22-25144	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-38271221	FDA UDI	Class I	Active
Acapella One	05-099-17-0000	FDA UDI	Class I	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT50-9545	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-20130	FDA UDI	Class II	Active
Tiger Shark System	P070-2411066	FDA UDI	Class I	Active
HARRIER-SA Lumbar Interbody System	S-YP10-30403019	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-38270012	FDA UDI	Class I	Active
SHARK™ Lumbar Spacer System	PP22-28114	FDA UDI	Class II	Active
BLACKBIRD™ Spinal System	L070-0020	FDA UDI	Class I	Active
SHARK™ Lumbar Spacer System	PP10-20124	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET10-5580	FDA UDI	Class II	Active
Tigershark	P070-T281312	FDA UDI	Class II	Active
Tiger Shark System	S-VT12-50221217	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	E070-0029	FDA UDI	Class I	Active
Gibralt	05-000-20-4012	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P073-25070	FDA UDI	Class I	Active
Tiger Shark System	S-PT46-24126	FDA UDI	Class II	Active
BLACKBIRD Spinal System	LT11-4530	FDA UDI	Class II	Active
LANCER™/THUNDERBOLT™ Pedicle Screw System	M070-0052	FDA UDI	Class I	Active
Gibralt	05-004-09-3242	FDA UDI	Class II	Active
Proliant Posterior Pedicle Screw & Hook Fixation System	05-052-02-0300	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	S-YP10-28361013	FDA UDI	Class II	Active
Tiger Shark	P070-6105	FDA UDI	Class I	Active
Tiger Shark System	S-VT12-40170015	FDA UDI	Class II	Active

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