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	JP10-26200408	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET20-4054	FDA UDI	Class II	Active
HydraLok	PS75040	FDA UDI	Class II	Active
Triton	S-QT10-1455	FDA UDI	Class II	Active
BLACKBIRD Spinal System	LT21-3530	FDA UDI	Class II	Active
Tiger Shark System	P070-241106	FDA UDI	Class I	Active
TiGER SHARK Interbody Fusion System	S-PT36-32186	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH30-1618411	FDA UDI	Class II	Active
Tiger Shark System	S-VT12-55221213	FDA UDI	Class II	Active
Thunderbolt	MT11-7035-080	FDA UDI	Class II	Active
THUNDERBOLT Minimally Invasive Pedicle Screw Systems	MT32-10560	FDA UDI	Class II	Active
Tiger Shark System	S-VT12-55170017	FDA UDI	Class II	Active
LANCER Pedicle Screw System	MT30-6075	FDA UDI	Class II	Active
Octane Straight PC	05-072-04-2415	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT50-5580	FDA UDI	Class II	Active
BLACKBIRD™ Spinal System	LT40-S200	FDA UDI	Class II	Active
VEO Lateral Interbody Fusion System	VT10-65170613	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	V070-01775	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	E070-0034	FDA UDI	Class I	Active
LANCER™ Pedicle Screw System	MT60-4555	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	S-YT60-28361015	FDA UDI	Class II	Active
TiGER SHARK Interbody Fusion System	S-PT36-24126	FDA UDI	Class II	Active
BLACKBIRD Spinal System	LT11-4520	FDA UDI	Class II	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-CN1416607	FDA UDI	Class I	Active
TYPHOON™Facet Screw Fixation System	KT20-5535	FDA UDI	U	Active
Ascendant	05-090-11-1811	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP20-30220412	FDA UDI	Class II	Active
BLACKBIRD™ Spinal System	L070-0033L	FDA UDI	Class I	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT50-75100	FDA UDI	Class II	Active
Tiger Shark System	S-VT12-65220011	FDA UDI	Class II	Active
Tiger Shark System	S-VT12-50170613	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System	P070-CUP04	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-34250010	FDA UDI	Class I	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-1214007	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-2312	FDA UDI	Class I	Active
Octane M	05-041-01-2612	FDA UDI	Class II	Active
Silverbolt/Mainframe	200-5630	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH30-1616408	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	Y070-28362519C	FDA UDI	Class II	Active
BLACKHAWK Cervical Spacer System	S-TT20-1614C06	FDA UDI	Class II	Active
Triton	S-QT10-1440	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	Y070-26320806W	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	22-0466-17	FDA UDI	Class II	Active
Proliant Posterior Pedicle Screw & Hook Fixation System	05-052-12-0045	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET50-7025	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	RH20-1616411	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT40-S030	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT20-S240	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET10-80110	FDA UDI	Class II	Active
Gibralt	05-000-26-3542	FDA UDI	Class II	Active

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