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
TOMCAT™ Cervical Spinal System	R070-1618812	FDA UDI	Class I	Active
HydraLok	PS75035	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	20-3227	FDA UDI	Class I	Active
TYPHOON™Facet Screw Fixation System	K070-0006	FDA UDI	Class I	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MC20-P035	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH20-1618811	FDA UDI	Class II	Active
Silverbolt/Mainframe Instruments	200-9703	FDA UDI	Class I	Active
Tiger Shark Spinal System	P070-32146W	FDA UDI	Class II	Active
LANCER/THUNDERBOLT Pedicle Screw System	M070-0113	FDA UDI	Class I	Active
Silverbolt/Mainframe	201-2035	FDA UDI	Class II	Active
Proliant	05-050-00-7525	FDA UDI	Class II	Active
Octane Straight	05-071-03-2413	FDA UDI	Class II	Active
HydraLok	PS50040	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	V070-61708	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P072-25140	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	21-0476	FDA UDI	Class I	Active
BLACKBIRD Spinal System	LT11-4528	FDA UDI	Class II	Active
Navigation	NV70-QT08	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	ET10-55100	FDA UDI	Class II	Active
Ambassador	05-100-03-0042	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-38271214	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-N1412408	FDA UDI	Class I	Active
Octane Straight	05-071-01-2410	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	21-0641	FDA UDI	Class I	Active
TOMCAT Cervical Spinal System	S-RH30-1616706	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MC20-S310	FDA UDI	Class II	Active
Proliant	05-050-00-5540	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	SPCL-PAA07	FDA UDI	Class I	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-N1214606	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	V070-0017	FDA UDI	Class I	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT10-8530	FDA UDI	Class II	Active
Octane M	05-041-06-3008	FDA UDI	Class II	Active
VEO Lateral Interbody Fusion System	VT10-45170613	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	20-3100	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	22-0469-25	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET10-6025	FDA UDI	Class II	Active
HAWKEYE™ Vertebral Body Replacement (VBR)	DP30-1214649	FDA UDI	Class II	Active
Ambassador Cervical Plate System	05-109-22-2013	FDA UDI	Class I	Active
LANCER™ Pedicle Screw System	MC40-H120	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET50-5030	FDA UDI	Class II	Active
BLACKBIRD™ Spinal System	LT10-4024	FDA UDI	Class II	Active
VEO Lateral Interbody Fusion System	VT10-45170617	FDA UDI	Class II	Active
TYPHOON™Facet Screw Fixation System	K070-AST44	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	ET10-8090	FDA UDI	Class II	Active
HARPOON™ Lumbar Spacer System	PP42-28104	FDA UDI	Class II	Active
Silverbolt/Mainframe	200-0470	FDA UDI	Class II	Active
Silverbolt/Mainframe Instruments	SK-004639	FDA UDI	Class I	Active
LANCER™/THUNDERBOLT™ Pedicle Screw System	SPCL-M001	FDA UDI	Class I	Active
Harrier-SA Lumbar Interbody System	Y070-30401015C	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	ET30-8550	FDA UDI	Class II	Active

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