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	LT10-4532	FDA UDI	Class II	Active
SCS Spinal System	2T20-CD8L	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-6570	FDA UDI	Class II	Active
Harrier-Sa	Y070-0058	FDA UDI	Class I	Active
TOMCAT Cervical Spinal System	S-RH20-1412810	FDA UDI	Class II	Active
VEO Lateral Interbody Fusion System	V070-121713P	FDA UDI	Class II	Active
LANCER/THUNDERBOLT Pedicle Screw System	M070-LS224	FDA UDI	Class I	Active
Tiger Shark System	S-VT12-50170009	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH20-1412410	FDA UDI	Class II	Active
Proliant	05-050-02-7550	FDA UDI	Class II	Active
SHARK Lumbar Spacer System	PT22-22174	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP20-30220008	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP50-42300010	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	28-0112	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	22-0362	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-H006	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP20-30220608	FDA UDI	Class II	Active
ORIA Zenith® Cervical Plate System	F070-4025	FDA UDI	Class I	Active
Dynabolt	300-4275	FDA UDI	Class II	Active
Octane T	05-049-02-0010	FDA UDI	Class I	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-14160849	FDA UDI	Class II	Active
LANCER Pedicle Screw System	MT31-5540	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	V070-0107	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-42300816	FDA UDI	Class I	Active
Octane Straight PC	05-072-01-2812	FDA UDI	Class II	Active
Tiger Shark System	P070-2811086	FDA UDI	Class I	Active
Acapella One	05-099-04-1600	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	SPCL-P012	FDA UDI	Class I	Active
LANCER™/THUNDERBOLT™ Pedicle Screw System	M070-0095	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-34250008	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-42300015	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	22-0567	FDA UDI	Class I	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-1214005	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-6056	FDA UDI	Class I	Active
Tiger Shark System	S-VT12-40170609	FDA UDI	Class II	Active
LANCER Pedicle Screw System	MT30-6065	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-32076	FDA UDI	Class II	Active
Octane Straight Intervertebral Fusion Device	SK-009584-08	FDA UDI	Class I	Active
Tomcat Cervical Spinal System	S-RH20-1616509	FDA UDI	Class II	Active
SHARK™ Lumbar Spacer System	PP22-22124	FDA UDI	Class II	Active
LANCER Pedicle Screw System	MT30-12540	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	22-0489-02	FDA UDI	Class II	Active
BLACKBIRD™ Spinal System	L070-0022	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	ET10-4540	FDA UDI	Class II	Active
VEO Lateral Interbody Fusion System	V070-B122215	FDA UDI	Class I	Active
Acapella One	05-099-31-1611	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-Z011	FDA UDI	Class I	Active
SHARK™ Lumbar Spacer System	PP20-28104	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP30-34250413	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P072-28100	FDA UDI	Class I	Active

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