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
Thunderbolt	MT11-5580-120	FDA UDI	Class II	Active
Oracle Expandable Reactor System	500-9230	FDA UDI	Class I	Active
ORIA XENA® Top Clip System	CT10-BP865	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-34250412	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-1614010	FDA UDI	Class I	Active
SHARK™ Lumbar Spacer System	PP20-28100	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT20-P060	FDA UDI	Class II	Active
Acapella One	05-099-28-1807	FDA UDI	Class I	Active
Ambassador	05-100-09-4521	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT40-H050	FDA UDI	Class II	Active
HARPOON™ Lumbar Spacer System	PP42-25160	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MC40-H050	FDA UDI	Class II	Active
HAWKEYE™ Vertebral Body Replacement (VBR)	DP30-1214618	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT10-4565	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT20-S115	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET10-4530	FDA UDI	Class II	Active
Triton	S-QT10-1460	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-32126	FDA UDI	Class II	Active
Acapella One	05-090-02-1610	FDA UDI	Class II	Active
Ascendant	05-090-11-1408	FDA UDI	Class II	Active
Thunderbolt	MT11-6065-120	FDA UDI	Class II	Active
Classic ACP	27414-013	FDA UDI	Class II	Active
Ambassador	05-100-09-4512	FDA UDI	Class II	Active
Tiger Shark System	S-PT46-28146	FDA UDI	Class II	Active
Oracle Expandable Reactor System	500-9040	FDA UDI	Class I	Active
HARPOON™ Lumbar Spacer System	PP42-28100	FDA UDI	Class II	Active
Tiger Shark Spinal System	P070-32166W	FDA UDI	Class II	Active
Octane T	05-049-01-0011	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-1514	FDA UDI	Class I	Active
LANCER™/THUNDERBOLT™ Pedicle Screw System	M070-0045	FDA UDI	Class I	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-CN1416608	FDA UDI	Class I	Active
Tiger Shark System	S-VT12-40170613	FDA UDI	Class II	Active
Gibralt	05-004-09-3848	FDA UDI	Class II	Active
Gibralt	05-000-26-4042	FDA UDI	Class II	Active
Octane Straight PC	05-072-04-2811	FDA UDI	Class II	Active
Ascendant	05-090-11-1410	FDA UDI	Class II	Active
Ascendant PC	05-090-31-1412	FDA UDI	Class II	Active
Octane Straight PC	05-072-03-2815	FDA UDI	Class II	Active
SCS CLARIS Spinal Screws	2T10E7-35	FDA UDI	Class II	Active
Silverbolt/Mainframe	200-5655	FDA UDI	Class II	Active
ORIA™ CLARIS Spinal Clip System	2T10-5V40	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT30-6540	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-5055	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	22-0475-05	FDA UDI	Class II	Active
Proliant Posterior Pedicle Screw & Hook Fixation System	05-050-12-5560	FDA UDI	Class II	Active
Ambassador Cervical Plate System	05-109-22-2015	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP25-30222017	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	RH30-1618006	FDA UDI	Class II	Active
ORIA Zenith® Cervical Plate System	F070-LF12	FDA UDI	Class I	Active
Thunderbolt	MT11-5575-120	FDA UDI	Class II	Active

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