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	MT11-95110-120	FDA UDI	Class II	Active
Thunderbolt	MT11-6030-080	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-201212	FDA UDI	Class II	Active
Octane T	600-9010	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P073-25180	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	22-0466-27	FDA UDI	Class II	Active
Ascendant	05-099-31-1607N	FDA UDI	Class I	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT20-P095	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT50-55110	FDA UDI	Class II	Active
Ambassador	05-109-22-2416	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-1614709	FDA UDI	Class I	Active
LANCER™ Pedicle Screw System	MC40-P115	FDA UDI	Class II	Active
Thunderbolt	MT11-6565-120	FDA UDI	Class II	Active
BLACKBIRD™ Spinal System	LT40-S100	FDA UDI	Class II	Active
Octane T	600-9315	FDA UDI	Class I	Active
HARRIER-SA Lumbar Interbody System	S-YP10-26321017	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP50-42301219	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	20-2571	FDA UDI	Class I	Active
Ascendant	05-099-01-0024	FDA UDI	Class I	Active
Thunderbolt	MT11-9575-120	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-6020	FDA UDI	Class I	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-1214006	FDA UDI	Class I	Active
Thunderbolt	MT11-10530-120	FDA UDI	Class II	Active
Ascendant PC	05-090-30-1605	FDA UDI	Class II	Active
LANCER/THUNDERBOLT Pedicle Screw System	M070-KTS322	FDA UDI	Class I	Active
Tomcat Cervical Spinal System	S-RH20-1616511	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP50-42300419	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-34250610	FDA UDI	Class I	Active
Octane Straight PC	05-072-01-3206	FDA UDI	Class II	Active
Octane Straight PC	05-072-03-2809	FDA UDI	Class II	Active
Proliant Posterior Pedicle Screw & Hook Fixation System	05-050-00-8590	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	T070-28070	FDA UDI	Class I	Active
LANCER™/THUNDERBOLT™ Pedicle Screw System	M070-0058	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-2109	FDA UDI	Class I	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-1214605	FDA UDI	Class I	Active
ORIA Zenith® Cervical Plate System	FT20-E351	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT20-S350	FDA UDI	Class II	Active
SHARK™ Lumbar Spacer System	PP20-22180	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP30-34251213	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	20-3301-10	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	RH20-1614409	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH30-1412810	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT50-4570	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-34250020	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-1412811	FDA UDI	Class I	Active
HAWKEYE™ Vertebral Body Replacement (VBR)	DP40-1416629	FDA UDI	Class II	Active
Ascendant PC	05-090-32-1807	FDA UDI	Class II	Active
Ascendant	05-090-10-1810	FDA UDI	Class II	Active
Silverbolt/Mainframe	201-2240	FDA UDI	Class II	Active
Proliant	05-050-00-7530	FDA UDI	Class II	Active

Choicespine, LP

What Choicespine, LP makes

Frequently asked questions

Information

Catalogue (9808)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities