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
Tiger Shark System	P070-32146	FDA UDI	Class II	Active
Octane Straight	05-071-04-2814	FDA UDI	Class II	Active
Acapella One	05-090-03-1405	FDA UDI	Class II	Active
LANCER/THUNDERBOLT Pedicle Screw System	M070-LS320	FDA UDI	Class I	Active
Ambassador	05-100-09-4011	FDA UDI	Class II	Active
Thunderbolt	MT11-70110-080	FDA UDI	Class II	Active
Tiger Shark System	D070-DS018151112	FDA UDI	Class I	Active
Tiger Shark System	P070-2411136	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	ET10-4570	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT10-7530	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH30-1616806	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-38270813	FDA UDI	Class I	Active
ORIA™ CLARIS Spinal Clip System	2T46-T090	FDA UDI	Class II	Active
BLACKHAWK Cervical Spacer System	S-TT20-1614605	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH20-1412812	FDA UDI	Class II	Active
VEO Lateral Interbody Fusion System	VT10-50170611	FDA UDI	Class II	Active
Tiger Shark	P070-50130614	FDA UDI	Class I	Active
Altes	27303	FDA UDI	Class II	Active
ORIA XENA® Top Clip System	C070-6004	FDA UDI	Class I	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MC20-P045	FDA UDI	Class II	Active
Tomcat Cervical Spinal System	S-RH20-1618508	FDA UDI	Class II	Active
LANCER Pedicle Screw System	MT30-12570	FDA UDI	Class II	Active
Tiger Shark System	P070-241306	FDA UDI	Class I	Active
THUNDERBOLT™ Minimally Invasive and LANCER™ Open Pedicle Screw System	MT80-FLL96	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	E070-0043	FDA UDI	Class I	Active
LANCER™ Pedicle Screw System	MT30-5560	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	22-0357	FDA UDI	Class I	Active
TOMCAT Cervical Spinal System	S-RH20-1614410	FDA UDI	Class II	Active
Harrier-Sa	Y070-0059	FDA UDI	Class I	Active
Thunderbolt	MT11-5570-080	FDA UDI	Class II	Active
Triton	S-QT10-0850	FDA UDI	Class II	Active
Gibralt	05-000-04-4544	FDA UDI	U	Active
Ambassador Cervical Plate System	05-109-22-2519	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP20-30221218	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	22-0480	FDA UDI	Class I	Active
SHARK™ Lumbar Spacer System	PP10-20084	FDA UDI	Class II	Active
FALCON™ Anterior Cervical Plate	FT10-BL414	FDA UDI	Class II	Active
TYPHOON™Facet Screw Fixation System	K070-ACD54	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	ET30-6525	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET10-8050	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	22-0475-06	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-7550	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET10-6080	FDA UDI	Class II	Active
SCS Spinal System	2T30-TC02	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET10-5530	FDA UDI	Class II	Active
TYPHOON™Facet Screw Fixation System	K070-SD5540	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-1412509	FDA UDI	Class I	Active
HARPOON™ Lumbar Spacer System	PP40-25150	FDA UDI	Class II	Active
Gibralt	05-000-20-4032	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	S-YP10-28362515	FDA UDI	Class II	Active

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