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 System	P070-2809076	FDA UDI	Class I	Active
Octane Straight	05-079-04-0000	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-1212	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	SPCL-R001	FDA UDI	Class I	Active
Tomcat Cervical Spinal System	S-RH20-1614512	FDA UDI	Class II	Active
LANCER™/THUNDERBOLT™ Pedicle Screw System	M070-0005	FDA UDI	Class I	Active
ORIA™ CLARIS Spinal Clip System	2T10-5V45	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-85110	FDA UDI	Class II	Active
Ascendant PC	05-090-32-1408	FDA UDI	Class II	Active
Ambassador	05-100-07-4516	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT60-4590	FDA UDI	Class II	Active
Thunderbolt	MT11-7045-120	FDA UDI	Class II	Active
BLACKHAWK Cervical Spacer System	05-090-21-1409	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	SPCL-P058	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	SPCL-E010	FDA UDI	Class I	Active
Tiger Shark System	S-VT12-60220013	FDA UDI	Class II	Active
Thunderbolt	MT11-7580-080	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	YT40-Z012	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP10-26200616	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP20-30220819	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	RH30-1616007	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-8025	FDA UDI	Class II	Active
FALCON™ Anterior Cervical Plate	FT10-BP410	FDA UDI	Class II	Active
Blackbird HLS	L070-1006	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MC40-H150	FDA UDI	Class II	Active
Ambassador Cervical Plate System	05-109-22-2019	FDA UDI	Class I	Active
Acapella One	05-099-07-1804	FDA UDI	Class I	Active
ORIA XENA® Top Clip System	C070-1043	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	ET50-7065	FDA UDI	Class II	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-12140031	FDA UDI	Class II	Active
SHARK Lumbar Spacer System	PT22-25134	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP40-38270614	FDA UDI	Class II	Active
LANCER™/THUNDERBOLT™ Pedicle Screw System	M070-0034	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-0005	FDA UDI	Class I	Active
ORIA Zenith® Cervical Plate System	FT20-E347	FDA UDI	Class II	Active
Harrier-SA LUMBAR INTERBODY SYSTEM	Y070-24091011B	FDA UDI	Class I	Active
Tiger Shark System	S-PT35-24106	FDA UDI	Class II	Active
Acapella One	05-090-03-1606	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	Y070-0035	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT10-8575	FDA UDI	Class II	Active
Thunderbolt	MT11-6055-080	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-42300411	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	T070-25140S	FDA UDI	Class I	Active
Tiger Shark System	S-PT34-28160	FDA UDI	Class II	Active
Tigershark	P070-5000	FDA UDI	Class I	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-CN1416610	FDA UDI	Class I	Active
Octane Straight PC	05-072-03-2407	FDA UDI	Class II	Active
Tiger Shark System	S-PT46-36116	FDA UDI	Class II	Active
HARPOON™ Lumbar Spacer System	PP40-25174	FDA UDI	Class II	Active
Acapella One	05-099-16-0001	FDA UDI	Class I	Active

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