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
HAWKEYE™ Vertebral Body Replacement (VBR)	DP40-1416029	FDA UDI	Class II	Active
Gibralt	05-004-10-2230	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP40-38270017	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	R070-N1412012	FDA UDI	Class I	Active
TYPHOON™Facet Screw Fixation System	KT20-5540	FDA UDI	U	Active
Tiger Shark System	S-PT46-32086	FDA UDI	Class II	Active
Tiger Shark System	S-VT12-65170015	FDA UDI	Class II	Active
Silverbolt/Mainframe	200-0297	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	V070-0111L	FDA UDI	Class I	Active
Proliant Posterior Pedicle Screw & Hook Fixation System	05-050-12-1001	FDA UDI	Class II	Active
Thunderbolt	NV70-M160-01	FDA UDI	Class I	Active
Lancer Open Pedicle Screw System	M070-0130	FDA UDI	Class II	Active
BLACKBIRD Spinal System	LT25-4026	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-201712	FDA UDI	Class II	Active
Thunderbolt	MT11-10555-120	FDA UDI	Class II	Active
Thunderbolt	MT11-7040-080	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-321412	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P073-28170	FDA UDI	Class I	Active
Oracle Expandable Reactor System	500-9340	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	22-0466-05	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-1513	FDA UDI	Class I	Active
SHARK™ Lumbar Spacer System	PP22-25080	FDA UDI	Class II	Active
TiGER SHARK Interbody Fusion System	S-PT36-32146	FDA UDI	Class II	Active
BLACKBIRD Spinal System	LT11-4022	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-280612	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT10-45110	FDA UDI	Class II	Active
ORIA Zenith® Cervical Plate System	FT20-E341	FDA UDI	Class II	Active
Thunderbolt	M070-0202	FDA UDI	Class I	Active
THUNDERBOLT Minimally Invasive Pedicle Screw Systems	MT10-12575	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-38270020	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-1618408	FDA UDI	Class I	Active
Silverbolt/Mainframe	200-0240	FDA UDI	Class II	Active
Thunderbolt	MT11-7555-080	FDA UDI	Class II	Active
Ascendant	05-099-118-0000	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-2209	FDA UDI	Class I	Active
Thunderbolt	MT11-5555-080	FDA UDI	Class II	Active
BLACKBIRD™ Spinal System	LC40-S200	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	S-YP10-26321513	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	R070-1614507	FDA UDI	Class I	Active
Proliant	05-050-00-8535	FDA UDI	Class II	Active
SHARK™ Lumbar Spacer System	PP22-25180	FDA UDI	Class II	Active
Ascendant PC	05-090-32-1410	FDA UDI	Class II	Active
Ambassador	05-100-08-4513	FDA UDI	Class II	Active
Tiger Shark System	P070-320906	FDA UDI	Class I	Active
Silverbolt/Mainframe	200-0290	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET10-7540	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	20-3143	FDA UDI	Class I	Active
LANCER Pedicle Screw System	MT30-7090	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-C204	FDA UDI	Class I	Active
BLACKHAWK Cervical Spacer System	05-090-22-1409	FDA UDI	Class II	Active

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