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
BLACKBIRD™ Spinal System	LC40-T560	FDA UDI	Class II	Active
ORIA™ Spinal Clip System	2T10-BD555	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT40-S100	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT60-7550	FDA UDI	Class II	Active
Octane T	600-9115	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-0002	FDA UDI	Class I	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MC20-S130	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET50-7080	FDA UDI	Class II	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-12140035	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	R070-0024	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-34250413	FDA UDI	Class I	Active
THUNDERBOLT™ Minimally Invasive and LANCER™ Open Pedicle Screw System	MT80-ELS60	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT30-9570	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-6036	FDA UDI	Class I	Active
Silverbolt/Mainframe	200-2075	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	22-0476-03	FDA UDI	Class II	Active
Blackbird HLS	LT50-0208	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	R070-0008	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	RT10-D4014	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	RH20-1618807	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	V070-0006	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	20-3573	FDA UDI	Class I	Active
SHARK™ Lumbar Spacer System	PP20-28150	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	S-YP10-28361017	FDA UDI	Class II	Active
Tiger Shark System	S-VT12-65170608	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH20-1614012	FDA UDI	Class II	Active
THUNDERBOLT Minimally Invasive Pedicle Screw Systems	MT10-11545	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-20144	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-N1614410	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-38270616	FDA UDI	Class I	Active
LANCER™ Pedicle Screw System	MT60-6580	FDA UDI	Class II	Active
THUNDERBOLT Minimally Invasive Pedicle Screw Systems	MT10-11540	FDA UDI	Class II	Active
Ambassador	05-100-07-4521	FDA UDI	Class II	Active
ORIA XENA® Top Clip System	CT10-BP940	FDA UDI	Class II	Active
BLACKBIRD™ Spinal System	LT40-P040	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	YT40-Z015	FDA UDI	Class II	Active
Thunderbolt	MT11-7575-120	FDA UDI	Class II	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-14160844	FDA UDI	Class II	Active
VEO Lateral Interbody Fusion System	VT10-55170608	FDA UDI	Class II	Active
BLACKBIRD Spinal System	LT21-4022	FDA UDI	Class II	Active
FALCON™ Anterior Cervical Plate	FT10-BP420	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET50-7075	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	SPCL-P041	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-34251212	FDA UDI	Class I	Active
HARPOON™ Lumbar Spacer System	PP42-25094	FDA UDI	Class II	Active
Acapella One	05-099-05-1606	FDA UDI	Class I	Active
SHARK Lumbar Spacer System	PT22-28094	FDA UDI	Class II	Active
VEO Lateral Interbody Fusion System	V070-62208P	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MC40-P125	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J070-0030	FDA UDI	Class I	Active

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