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
Octane T	05-049-02-0007	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	SPCL-P071	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-38270621	FDA UDI	Class I	Active
TOMCAT Cervical Spinal System	S-RH30-1614812	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-8080	FDA UDI	Class II	Active
Thunderbolt	M070-0213	FDA UDI	Class I	Active
Tigershark	P070-T401206	FDA UDI	Class II	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-N1416612	FDA UDI	Class I	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-14160045	FDA UDI	Class II	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-12140058	FDA UDI	Class II	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-N1214611	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	22-0468-14	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT30-55110	FDA UDI	Class II	Active
Tiger Shark System	P070-62807	FDA UDI	Class I	Active
HARRIER-SA Lumbar Interbody System	S-YP10-28361019	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-20176	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-38270414	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	25-9028	FDA UDI	Class I	Active
TOMCAT Cervical Spinal System	S-RH20-1616812	FDA UDI	Class II	Active
Octane A	602-98-1515	FDA UDI	Class II	Active
Thunderbolt	MT11-7570-120	FDA UDI	Class II	Active
Tiger Shark System	S-PT46-28106	FDA UDI	Class II	Active
BLACKBIRD Spinal System	LT25-3522	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MC40-S390	FDA UDI	Class II	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-14160020	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	S-YP10-30401015	FDA UDI	Class II	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-12140033	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP40-38270616	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-281312	FDA UDI	Class II	Active
HAWKEYE™ Vertebral Body Replacement (VBR)	DP30-1214614	FDA UDI	Class II	Active
Thunderbolt	MT11-6535-120	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-42301216	FDA UDI	Class I	Active
Acapella One	05-090-03-1610	FDA UDI	Class II	Active
Ambassador	05-100-07-4512	FDA UDI	Class II	Active
Octane Straight PC	05-072-03-2415	FDA UDI	Class II	Active
Ambassador	05-100-05-0080	FDA UDI	Class II	Active
TIGER SHARK Cervical System	S-TC10-1815605	FDA UDI	Class II	Active
VEO Lateral Interbody Fusion System	V070-0121	FDA UDI	Class I	Active
HARRIER-SA Lumbar Interbody System	Y070-28361013	FDA UDI	Class II	Active
Ambassador	05-100-07-4513	FDA UDI	Class II	Active
Tiger Shark System	S-PT35-2407L	FDA UDI	Class II	Active
Gibralt	05-000-20-4028	FDA UDI	Class II	Active
Ambassador	05-100-08-4512	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-240812	FDA UDI	Class II	Active
TiGER SHARK Interbody Fusion System	S-PT36-32156	FDA UDI	Class II	Active
HydraLok	28240-110	FDA UDI	Class II	Active
Octane Straight	05-071-01-3213	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	21-0602	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	22-0366	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	ET30-80110	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