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
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-1415	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-1616008	FDA UDI	Class I	Active
Ascendant	05-099-31-1609N	FDA UDI	Class I	Active
Tiger Shark System	S-VT12-45221215	FDA UDI	Class II	Active
Gibralt	05-000-04-4528	FDA UDI	U	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-1411	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-6017	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	RH30-1618809	FDA UDI	Class II	Active
STEALTH™ Anterior Cervical Interbody Spacer	DP10-1214006	FDA UDI	Class II	Active
Starfire Pedicle Screw System	E070-0074	FDA UDI	Class I	Active
Octane Straight	05-079-07-0000	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-1618411	FDA UDI	Class I	Active
Acapella One	05-099-29-1810	FDA UDI	Class I	Active
HARPOON™ Lumbar Spacer System	PP40-32140	FDA UDI	Class II	Active
Tiger Shark System	S-PT46-24086	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP50-42301221	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	R070-N1614407	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	RT10-T4014	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MC20-S440	FDA UDI	Class II	Active
HARPOON™ Lumbar Spacer System	PP40-28100	FDA UDI	Class II	Active
Gibralt	05-004-09-4452	FDA UDI	Class II	Active
Ambassador Cervical Plate System	05-109-22-2012	FDA UDI	Class I	Active
Acapella One	05-099-07-1606	FDA UDI	Class I	Active
Thunderbolt	MT11-4550-120	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	E070-0036	FDA UDI	Class I	Active
THUNDERBOLT Minimally Invasive Pedicle Screw Systems	MT10-11550	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	SPCL-P001	FDA UDI	Class I	Active
VEO Lateral Interbody Fusion System	V070-0008	FDA UDI	Class I	Active
SCS CLARIS Spinal Screws	2T10E5-50	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT20-P035	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET50-7550	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET10-50100	FDA UDI	Class II	Active
Ambassador	05-100-10-4020	FDA UDI	Class II	Active
Silverbolt/Mainframe	200-2230	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	22-0550	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	RH20-1618012	FDA UDI	Class II	Active
HARPOON™ Lumbar Spacer System	PP40-25164	FDA UDI	Class II	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-12140860	FDA UDI	Class II	Active
HAWKEYE™ Vertebral Body Replacement (VBR)	DP40-1416632	FDA UDI	Class II	Active
HAWKEYE™ Vertebral Body Replacement (VBR)	DP30-1214036	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	20-3014	FDA UDI	Class I	Active
Proliant	05-052-11-0035	FDA UDI	Class II	Active
Tiger Shark	P070-5010B	FDA UDI	Class I	Active
Thunderbolt	MT11-9535-120	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	T070-25100	FDA UDI	Class I	Active
SCS Spinal System	2T30-DF0Z	FDA UDI	Class II	Active
SHARK™ Lumbar Spacer System	PP20-22090	FDA UDI	Class II	Active
Thunderbolt	MT11-6040-120	FDA UDI	Class II	Active
Oracle Expandable Reactor System	500-9010	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-1618007	FDA UDI	Class I	Active

Choicespine, LP

What Choicespine, LP makes

Frequently asked questions

Information

Catalogue (9808)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities