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	05-071-02-2413	FDA UDI	Class II	Active
Gibralt	05-000-26-3532	FDA UDI	Class II	Active
Thunderbolt	MT11-5090-080	FDA UDI	Class II	Active
Thunderbolt	MT11-9560-080	FDA UDI	Class II	Active
THUNDERBOLT Minimally Invasive Pedicle Screw Systems	MT32-9525	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	R070-1412706	FDA UDI	Class I	Active
LANCER™ Pedicle Screw System	MC40-H240	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	Y070-26321519C	FDA UDI	Class II	Active
THUNDERBOLT Minimally Invasive Pedicle Screw Systems	MT32-10570	FDA UDI	Class II	Active
Tiger Shark	P070-5001-25	FDA UDI	Class I	Active
Harrier SA	Y070-28361010	FDA UDI	Class II	Active
Thunderbolt	MT11-8535-080	FDA UDI	Class II	Active
Tiger Shark	V070-1004	FDA UDI	Class I	Active
VEO Lateral Interbody Fusion System	V070-B122213	FDA UDI	Class I	Active
LANCER Pedicle Screw System	MT60-11535	FDA UDI	Class II	Active
BLACKHAWK Cervical Spacer System	T070-0003	FDA UDI	Class I	Active
HARRIER-SA Lumbar Interbody System	Y070-28362015	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P072-22150	FDA UDI	Class I	Active
Thunderbolt	MT11-75100-120	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	S-YT60-30401515	FDA UDI	Class II	Active
BLACKHAWK Cervical Spacer System	S-TT10-1614007	FDA UDI	Class II	Active
TiGER SHARK Interbody Fusion System	S-PT36-32126	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	S-YT10-30403023	FDA UDI	Class II	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-14160847	FDA UDI	Class II	Active
LANCER™/THUNDERBOLT™ Pedicle Screw System	SPCL-M014	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P073-25120	FDA UDI	Class I	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-C1214606	FDA UDI	Class I	Active
LANCER™/THUNDERBOLT™ Pedicle Screw System	M070-0062	FDA UDI	Class I	Active
LANCER Pedicle Screw System	MT40-DL15	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-34251221	FDA UDI	Class I	Active
HARPOON™ Lumbar Spacer System	PP42-25140	FDA UDI	Class II	Active
SHARK™ Lumbar Spacer System	PP10-20144	FDA UDI	Class II	Active
Gibralt	05-000-04-4538	FDA UDI	U	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP40-38271211	FDA UDI	Class II	Active
Tigershark	P070-T401006	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-28116	FDA UDI	Class II	Active
BLACKHAWK Cervical Spacer System	05-090-23-1407	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH20-1412010	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	Y070-28361015	FDA UDI	Class II	Active
Octane T	05-049-01-0006	FDA UDI	Class I	Active
Octane T	600-9022	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	22-0467-11	FDA UDI	Class II	Active
Tiger Shark System	P070-63211	FDA UDI	Class I	Active
Proliant Posterior Pedicle Screw & Hook Fixation System	05-050-12-3003	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-32096	FDA UDI	Class II	Active
Octane Straight Intervertebral Fusion Device	SK-009584-10	FDA UDI	Class I	Active
BLACKBIRD™ Spinal System	LT30-H06	FDA UDI	Class II	Active
Ascendant	05-090-12-1604	FDA UDI	Class II	Active
VEO Lateral Interbody Fusion System	V070-T61711R	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP10-26200410	FDA UDI	Class II	Active

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