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
STARFIRE™ Pedicle Screw System	ET10-6540	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH30-1616812	FDA UDI	Class II	Active
Octane Straight IR	PT23-32156	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	S-YT60-30401019	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	SPCL-P042	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-6055	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-Z007	FDA UDI	Class I	Active
TOMCAT Cervical Spinal System	S-RH30-1614806	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT60-4575	FDA UDI	Class II	Active
HORNET™Lumbar Spacer System	PP30-22180	FDA UDI	Class II	Active
Ascendant	05-090-12-1606	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-1410	FDA UDI	Class I	Active
THUNDERBOLT™ Minimally Invasive and LANCER™ Open Pedicle Screw System	M070-D005	FDA UDI	Class I	Active
LANCER™ Pedicle Screw System	MT30-5535	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-6070	FDA UDI	Class II	Active
Thunderbolt	MT11-8580-120	FDA UDI	Class II	Active
Ambassador	05-100-02-0024	FDA UDI	Class II	Active
Thunderbolt	MT11-9565-120	FDA UDI	Class II	Active
Silverbolt/Mainframe	200-0455	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP25-30222019	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH30-1618809	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT60-5590	FDA UDI	Class II	Active
Tiger Shark Spinal System	P070-28126W	FDA UDI	Class II	Active
Tiger Shark System	S-VT12-55171217	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	Y070-28362517C	FDA UDI	Class II	Active
Thunderbolt	MT11-4560-120	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive and LANCER™ Open Pedicle Screw System	M070-D009	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-1616007	FDA UDI	Class I	Active
Tigershark	P070-T401106	FDA UDI	Class II	Active
Raven Lumbar Plate System	Y070-1005	FDA UDI	Class I	Active
Tiger Shark System	S-VT12-55170615	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	S-YT10-26321017	FDA UDI	Class II	Active
Acapella One	05-099-29-1804	FDA UDI	Class I	Active
FALCON™ Anterior Cervical Plate	SPCL-A023	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	22-3301-08	FDA UDI	Class I	Active
Octane Straight Intervertebral Fusion Device	SK-008569-06	FDA UDI	Class I	Active
BLACKBIRD™ Spinal System	LT30-R3035	FDA UDI	Class II	Active
Tiger Shark System	P070-2411076	FDA UDI	Class I	Active
ORIA XENA® Top Clip System	CT10-BP725	FDA UDI	Class II	Active
Acapella One	05-099-29-1609	FDA UDI	Class I	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MC20-S105	FDA UDI	Class II	Active
Acapella One	05-099-29-1604	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	21-0725	FDA UDI	Class I	Active
LANCER™ Pedicle Screw System	MC40-S280	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	20-3598-01	FDA UDI	Class I	Active
Octane Straight PC	05-072-01-2815	FDA UDI	Class II	Active
Ambassador	05-100-01-0018	FDA UDI	Class II	Active
LANCER Pedicle Screw System	MT31-6525	FDA UDI	Class II	Active
LANCER™/THUNDERBOLT™ Pedicle Screw System	M070-0024	FDA UDI	Class I	Active
HARPOON™ Lumbar Spacer System	PP40-32154	FDA UDI	Class II	Active

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