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
TiGER SHARK Interbody Fusion System	D070-DS016140910	FDA UDI	Class II	Active
Tiger Shark System	S-VT12-45220013	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-20070	FDA UDI	Class II	Active
Octane M	05-049-03-1000	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	SPCL-P028	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-34251220	FDA UDI	Class I	Active
LANCER™/THUNDERBOLT™ Pedicle Screw System	M070-0044	FDA UDI	Class I	Active
SHARK™ Lumbar Spacer System	PP22-25130	FDA UDI	Class II	Active
Proliant	05-050-02-5540	FDA UDI	Class II	Active
BLACKHAWK Cervical Spacer System	S-TT10-1412008	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	S-YT60-30401015	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-321512	FDA UDI	Class II	Active
THUNDERBOLT Minimally Invasive Pedicle Screw Systems	MT10-10575	FDA UDI	Class II	Active
Veo	V070-A61715R	FDA UDI	Class I	Active
Tiger Shark System	P070-3209136	FDA UDI	Class I	Active
Proliant Posterior Pedicle Screw & Hook Fixation System	05-050-10-7560	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	S-YT10-28363021	FDA UDI	Class II	Active
Silverbolt/Mainframe	200-2025	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-6032	FDA UDI	Class I	Active
BLACKBIRD™ Spinal System	LT40-P140	FDA UDI	Class II	Active
Thunderbolt	M070-0153	FDA UDI	Class I	Active
LANCER Pedicle Screw System	MT40-DP080	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	R070-D010	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-N1614007	FDA UDI	Class I	Active
Tiger Shark System	S-VT12-50220017	FDA UDI	Class II	Active
LANCER Pedicle Screw System	MT30-12535	FDA UDI	Class II	Active
LANCER™/THUNDERBOLT™ Pedicle Screw System	M070-0080	FDA UDI	Class I	Active
LANCER Pedicle Screw System	MT30-12555	FDA UDI	Class II	Active
Acapella One	05-099-32-1407	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-42300415	FDA UDI	Class I	Active
Proliant Posterior Pedicle Screw & Hook Fixation System	05-050-10-4555	FDA UDI	Class II	Active
Stratofuse Cervical Allograft	BA070-0001	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-38270021	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	25-9029	FDA UDI	Class I	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-0002	FDA UDI	Class I	Active
Acapella One	05-099-05-1605	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-N0008	FDA UDI	Class I	Active
TOMCAT Cervical Spinal System	S-RH30-1616808	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP10-26200818	FDA UDI	Class II	Active
FALCON™ Anterior Cervical Plate	A070-0D12	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	E070-0047	FDA UDI	Class I	Active
SCS CLARIS Spinal Screws	2T10F5-45	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT40-H420	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT60-5545	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	S-YT60-26321013	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	R070-1412410	FDA UDI	Class I	Active
TIGER SHARK Cervical System	S-TC10-1815609	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH20-1616407	FDA UDI	Class II	Active
LANCER/THUNDERBOLT Pedicle Screw System	M070-LN220	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	ET10-8065	FDA UDI	Class II	Active

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