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
ORIA XENA® Top Clip System	CT10-BP750	FDA UDI	Class II	Active
Octane A	602-98-1213	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-6030	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	RH20-1614406	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	V070-0063	FDA UDI	Class I	Active
LANCER™ Pedicle Screw System	MT40-H180	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT20-P050	FDA UDI	Class II	Active
Acapella One	05-090-03-1605	FDA UDI	Class II	Active
LANCER/THUNDERBOLT Pedicle Screw System	M070-KTN320	FDA UDI	Class I	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT50-7550	FDA UDI	Class II	Active
BLACKHAWK Cervical Spacer System	S-TT20-1412610	FDA UDI	Class II	Active
Octane Straight	05-049-20-0015	FDA UDI	Class I	Active
TOMCAT Cervical Spinal System	S-RH20-1614710	FDA UDI	Class II	Active
ORIA™ Spinal Clip System	2T10-BD730	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT50-8525	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-6565	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-8545	FDA UDI	Class II	Active
Tiger Shark System	S-PT50-E3206	FDA UDI	Class II	Active
Blackbird HLS	LT50-0108	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	S-YT10-Z019	FDA UDI	Class II	Active
Silverbolt/Mainframe	200-5945	FDA UDI	Class II	Active
BLACKBIRD™ Spinal System	L070-0037	FDA UDI	Class I	Active
LANCER™ Pedicle Screw System	MT30-5545	FDA UDI	Class II	Active
TYPHOON™Facet Screw Fixation System	K070-ASD55	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	ET10-5090	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP30-34250812	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	22-0639	FDA UDI	Class I	Active
FALCON™ Anterior Cervical Plate	AT10-4068	FDA UDI	Class II	Active
Ambassador Cervical Plate System	05-109-02-2000	FDA UDI	Class I	Active
TOMCAT Cervical Spinal System	S-RH20-1614407	FDA UDI	Class II	Active
Blackbird HLS	L070-1008	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-8565	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	22-0467-08	FDA UDI	Class II	Active
SCS CLARIS Spinal Screws	2T10F7-50	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	SPCL-V001	FDA UDI	Class I	Active
Tiger Shark System	P070-321106	FDA UDI	Class I	Active
Proliant Posterior Pedicle Screw & Hook Fixation System	05-050-10-4525	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	S-YT10-26321013	FDA UDI	Class II	Active
HARPOON Lumbar Spacer System	PP40-36124	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH20-1618407	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P073-25080	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-6046	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	21-0775	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-1618010	FDA UDI	Class I	Active
ORIA XENA® Top Clip System	CT10-BP735	FDA UDI	Class II	Active
HARPOON™ Lumbar Spacer System	PP40-25084	FDA UDI	Class II	Active
Classic ACP	27413-015	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	S-YT60-28361512	FDA UDI	Class II	Active
Thunderbolt	MT11-55100-120	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-38270418	FDA UDI	Class I	Active

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