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
STARFIRE™ Pedicle Screw System	ET50-5560	FDA UDI	Class II	Active
Thunderbolt	MT11-5560-080	FDA UDI	Class II	Active
VEO Lateral Interbody Fusion System	V070-0033	FDA UDI	Class I	Active
LANCER Pedicle Screw System	MT40-DL35	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP55-42302016	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP30-34250616	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-5003	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	21-0770	FDA UDI	Class I	Active
Thunderbolt	MT11-7565-120	FDA UDI	Class II	Active
Ascendant	05-090-12-1412	FDA UDI	Class II	Active
THUNDERBOLT MI and LANCER Pedicle Screw System	MT40-DS00	FDA UDI	Class II	Active
BLACKBIRD Spinal System	LT15-4512	FDA UDI	Class II	Active
FALCON™ Anterior Cervical Plate	SPCL-A012	FDA UDI	Class I	Active
Octane T	600-9313	FDA UDI	Class I	Active
Thunderbolt	MT11-5050-120	FDA UDI	Class II	Active
Acapella One	05-099-07-1605	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-Z110	FDA UDI	Class I	Active
BLACKBIRD™ Spinal System	LC40-S140	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	20-3317	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	ET10-6530	FDA UDI	Class II	Active
HORNET™Lumbar Spacer System	PP30-22080	FDA UDI	Class II	Active
ORIA™ CLARIS Spinal Clip System	2T46-P050	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET50-5555	FDA UDI	Class II	Active
Octane Straight	05-071-01-3208	FDA UDI	Class II	Active
VEO Lateral Interbody Fusion System	VT10-45170611	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	S-YT60-26322019	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET10-5075	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT20-S070	FDA UDI	Class II	Active
STEALTH™ Anterior Cervical Interbody Spacer	DP20-1416610	FDA UDI	Class II	Active
VEO Lateral Interbody Fusion System	VT10-65220007	FDA UDI	Class II	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-C1416609	FDA UDI	Class I	Active
Acapella One	05-090-02-1406	FDA UDI	Class II	Active
FALCON™ Anterior Cervical Plate	A070-0012	FDA UDI	Class I	Active
HAWKEYE™ Vertebral Body Replacement (VBR)	DP40-1416019	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET10-5550	FDA UDI	Class II	Active
Proliant	05-052-01-0060	FDA UDI	Class II	Active
Tiger Shark System	P070-24176	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH30-1618407	FDA UDI	Class II	Active
Ambassador	05-100-10-4010	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	SPCL-PAA13	FDA UDI	Class I	Active
Triton	Q070-D014	FDA UDI	Class I	Active
THUNDERBOLT Minimally Invasive Pedicle Screw Systems	MT10-12590	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	S-YT10-28362521	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	SPCL-P023	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP10-26201215	FDA UDI	Class II	Active
ORIA™ CLARIS Spinal Clip System	7T20-AL03	FDA UDI	Class II	Active
BLACKBIRD™ Spinal System	LT40-T360	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	S-YT60-28361019	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	SPCL-P032	FDA UDI	Class I	Active
HARRIER-SA Lumbar Interbody System	S-YT40-Z021	FDA UDI	Class II	Active

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