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
Veo	V070-A61709L	FDA UDI	Class I	Active
Thunderbolt	MT11-7535-120	FDA UDI	Class II	Active
Acapella One	05-099-33-1607	FDA UDI	Class I	Active
Tiger Shark System	D070-DS618150506	FDA UDI	Class I	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-12140047	FDA UDI	Class II	Active
LANCER Pedicle Screw System	MT40-DL40	FDA UDI	Class II	Active
Acapella One	05-099-32-1607	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-1412009	FDA UDI	Class I	Active
HARRIER-SA Lumbar Interbody System	S-YP10-28362519	FDA UDI	Class II	Active
Blackbird HLS	LT50-0112	FDA UDI	Class II	Active
SHARK Lumbar Spacer System	PT22-25084	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	20-2365	FDA UDI	Class I	Active
TYPHOON™Facet Screw Fixation System	KT10-5530	FDA UDI	U	Active
HARRIER-SA Lumbar Interbody System	S-YT10-Z021	FDA UDI	Class II	Active
Acapella One	05-099-07-1611	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	V070-A2209	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	E070-0055	FDA UDI	Class I	Active
SHARK™ Lumbar Spacer System	PP20-28170	FDA UDI	Class II	Active
VEO Lateral Interbody Fusion System	VT10-40170615	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET50-8580	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT50-9540	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	V070-0025	FDA UDI	Class I	Active
BLACKBIRD™ Spinal System	LT40-S040	FDA UDI	Class II	Active
Tiger Shark System	S-PT50-A3205	FDA UDI	Class II	Active
HAWKEYE™ Vertebral Body Replacement (VBR)	DP40-1416624	FDA UDI	Class II	Active
FALCON™ Anterior Cervical Plate	AT10-3058	FDA UDI	Class II	Active
Thunderbolt	MT11-55100-080	FDA UDI	Class II	Active
Tiger Shark System	P070-2411116	FDA UDI	Class I	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-12140012	FDA UDI	Class II	Active
Octane T	600-9114	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-1208	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	22-0656	FDA UDI	Class I	Active
Tiger Shark M	P070-6124	FDA UDI	Class I	Active
Thunderbolt	MT11-5525-080	FDA UDI	Class II	Active
Silverbolt/Mainframe	200-2345	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT30-7570	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT10-9550	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT30-4550	FDA UDI	Class II	Active
Thunderbolt	MT11-8560-120	FDA UDI	Class II	Active
Triton	Q070-0018	FDA UDI	Class I	Active
VEO Lateral Interbody Fusion System	V070-121711	FDA UDI	Class I	Active
Gibralt	05-000-20-4022	FDA UDI	Class II	Active
Silverbolt/Mainframe	200-5365	FDA UDI	Class II	Active
Proliant	05-052-11-0080	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	V070-0108	FDA UDI	Class I	Active
HARRIER-SA Lumbar Interbody System	S-YP10-28361515	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-200812	FDA UDI	Class II	Active
Tiger Shark System	S-VT12-60220615	FDA UDI	Class II	Active
Tomcat Cervical Spinal System	S-RH20-1614509	FDA UDI	Class II	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-C1416606	FDA UDI	Class I	Active

Choicespine, LP

What Choicespine, LP makes

Frequently asked questions

Information

Catalogue (9808)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities