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
Ambassador Cervical Plate System	05-109-26-0000	FDA UDI	Class I	Active
Acapella One	05-099-07-1812	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-34250809	FDA UDI	Class I	Active
THUNDERBOLT™ Minimally Invasive and LANCER™ Open Pedicle Screw System	M070-D001	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	21-0544	FDA UDI	Class I	Active
LANCER Pedicle Screw System	MT30-6060	FDA UDI	Class II	Active
Gibralt	05-002-03-3570	FDA UDI	Class II	Active
VEO Lateral Interbody Fusion System	V070-B62213	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	22-0466-06	FDA UDI	Class II	Active
HORNET™Lumbar Spacer System	PP30-28100	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MC20-S160	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	20-2570	FDA UDI	Class I	Active
BLACKBIRD Spinal System	L070-0056	FDA UDI	Class I	Active
Tiger Shark System	S-VT12-50170608	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH30-1614808	FDA UDI	Class II	Active
SCS CLARIS Spinal Screws	2T10E9-40	FDA UDI	Class II	Active
Gibralt	05-009-12-0000	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-1412507	FDA UDI	Class I	Active
HARPOON™ Lumbar Spacer System	PP40-25130	FDA UDI	Class II	Active
SCS CLARIS Spinal Screws	2T10G6-50	FDA UDI	Class II	Active
HAWKEYE™ Vertebral Body Replacement (VBR)	DP30-1214033	FDA UDI	Class II	Active
Proliant Posterior Pedicle Screw & Hook Fixation System	05-050-10-8540	FDA UDI	Class II	Active
Tiger Shark System	S-VT12-45170609	FDA UDI	Class II	Active
Ambassador Cervical Plate System	05-109-22-2512	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-38270617	FDA UDI	Class I	Active
Octane Straight Intervertebral Fusion Device	SK-009584-14	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P072-28144	FDA UDI	Class I	Active
Ascendant	05-099-01-1006	FDA UDI	Class I	Active
HARPOON™ Lumbar Spacer System	PP42-25070	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-34250011	FDA UDI	Class I	Active
Tiger Shark C	D070-0014	FDA UDI	Class I	Active
Tiger Shark System	S-VT12-40170611	FDA UDI	Class II	Active
BLACKHAWK Cervical Spacer System	05-090-21-1606	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	S-YT60-28361517	FDA UDI	Class II	Active
Proliant Posterior Pedicle Screw & Hook Fixation System	05-052-12-0050	FDA UDI	Class II	Active
Dynabolt	300-4296	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-281612	FDA UDI	Class II	Active
Veo Lateral Spinal System	V070-0092	FDA UDI	Class I	Active
HARPOON™ Lumbar Spacer System	PP40-32164	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	20-2250	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	E070-0068	FDA UDI	Class I	Active
Acapella One	05-099-28-1611	FDA UDI	Class I	Active
BLACKBIRD™ Spinal System	LT10-3530	FDA UDI	Class II	Active
Acapella One	05-099-33-1410	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-1616811	FDA UDI	Class I	Active
FALCON™ Anterior Cervical Plate	SPCL-A015	FDA UDI	Class I	Active
LANCER Pedicle Screw System	MT30-12530	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT50-5565	FDA UDI	Class II	Active
Acapella One	05-099-33-1407	FDA UDI	Class I	Active
Acapella One	05-099-06-1405	FDA UDI	Class I	Active

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