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
HARRIER-SA Lumbar Interbody System	S-YP10-28363023	FDA UDI	Class II	Active
SCS CLARIS Spinal Screws	2T10E6-35	FDA UDI	Class II	Active
Tiger Shark System	P070-2411106	FDA UDI	Class I	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-14160038	FDA UDI	Class II	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-12140051	FDA UDI	Class II	Active
HARPOON Lumbar Spacer System	PP40-36104	FDA UDI	Class II	Active
Proliant Posterior Pedicle Screw & Hook System	05-059-14-0000	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	20-3869	FDA UDI	Class I	Active
LANCER™ Pedicle Screw System	MT40-P055	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH20-1614711	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH20-1614006	FDA UDI	Class II	Active
THUNDERBOLT Minimally Invasive Pedicle Screw Systems	MT10-105100	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	T070-25070	FDA UDI	Class I	Active
Octane T	05-049-02-0008	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	SPCL-PAA11	FDA UDI	Class I	Active
BLACKHAWK Cervical Spacer System	T070-0009A	FDA UDI	Class I	Active
Tiger Shark System	S-PT34-280712	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P072-28180	FDA UDI	Class I	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-1416010	FDA UDI	Class I	Active
Tiger Shark System	S-PT47-25086	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH30-1616012	FDA UDI	Class II	Active
Octane Straight	05-071-03-2814	FDA UDI	Class II	Active
Proliant Posterior Pedicle Screw & Hook Fixation System	05-050-10-4550	FDA UDI	Class II	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-12140817	FDA UDI	Class II	Active
Acapella One	05-099-29-1807	FDA UDI	Class I	Active
Ascendant PC	05-090-30-1811	FDA UDI	Class II	Active
Ambassador	05-100-04-0080	FDA UDI	Class II	Active
Gibralt	05-002-13-3550	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P073-25094	FDA UDI	Class I	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-14160040	FDA UDI	Class II	Active
Octane M	05-049-10-0000	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	21-0778	FDA UDI	Class I	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-1416609	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	22-0466-22	FDA UDI	Class II	Active
BLACKBIRD™ Spinal System	LT10-4016	FDA UDI	Class II	Active
Thunderbolt	M070-0211	FDA UDI	Class I	Active
ORIA XENA® Top Clip System	CT10-BP755	FDA UDI	Class II	Active
LANCER™/THUNDERBOLT™ Pedicle Screw System	MC20-P150	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT50-6550	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-1210	FDA UDI	Class I	Active
Tiger Shark System	S-PT47-32086	FDA UDI	Class II	Active
Octane Straight	05-071-02-3214	FDA UDI	Class II	Active
Gibralt	05-000-24-0925	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-24066	FDA UDI	Class II	Active
Gibralt	05-004-07-3560	FDA UDI	Class II	Active
VEO Lateral Interbody Fusion System	V070-01708S	FDA UDI	Class I	Active
Octane Straight PC	05-072-02-2412	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-24126	FDA UDI	Class II	Active
TIGER SHARK Cervical System	S-TC10-1815607	FDA UDI	Class II	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-N1214006	FDA UDI	Class I	Active

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