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
STARFIRE™ Pedicle Screw System	ET10-6030	FDA UDI	Class II	Active
Tiger Shark System	P070-281206	FDA UDI	Class I	Active
BLACKBIRD™ Spinal System	LC40-P080	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP10-26201209	FDA UDI	Class II	Active
Gibralt	05-009-11-2424	FDA UDI	Class I	Active
LANCER/THUNDERBOLT Pedicle Screw System	M070-LN222	FDA UDI	Class I	Active
Gibralt	05-002-13-3540	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP20-30220613	FDA UDI	Class II	Active
HAWKEYE™ Vertebral Body Replacement (VBR)	DP40-1416032	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP20-30220417	FDA UDI	Class II	Active
SCS Spinal System	2T20-CL12	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-7030	FDA UDI	Class II	Active
Ambassador	05-100-08-4018	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-2314	FDA UDI	Class I	Active
Acapella One	05-099-27-1410	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	V070-02209	FDA UDI	Class I	Active
SCS CLARIS Spinal Screws	2T10E8-40	FDA UDI	Class II	Active
FALCON™ Anterior Cervical Plate	FT10-BF420	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-8035	FDA UDI	Class II	Active
Octane Straight	05-071-01-3211	FDA UDI	Class II	Active
ORIA™ Spinal Clip System	2T10-BD440	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-6055	FDA UDI	Class II	Active
HAWKEYE™ Vertebral Body Replacement (VBR)	DP40-1416018	FDA UDI	Class II	Active
Proliant	05-052-01-0080	FDA UDI	Class II	Active
FALCON™ Anterior Cervical Plate	FT10-BL412	FDA UDI	Class II	Active
TYPHOON™Facet Screw Fixation System	KT20-4525	FDA UDI	U	Active
TOMCAT™ Cervical Spinal System	R070-Z006	FDA UDI	Class I	Active
Ambassador	05-100-08-4014	FDA UDI	Class II	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-0003	FDA UDI	Class I	Active
LANCER™ Pedicle Screw System	MC40-P130	FDA UDI	Class II	Active
Harrier SA	YT35-5040	FDA UDI	Class II	Active
Tiger Shark System	S-PT47-25146	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-8555	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-5560	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	RH20-1618008	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-1209	FDA UDI	Class I	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT50-6545	FDA UDI	Class II	Active
Thunderbolt	MT11-4540-120	FDA UDI	Class II	Active
Ascendant	05-090-11-1812	FDA UDI	Class II	Active
Tiger Shark System	S-VT12-40170008	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH20-1618709	FDA UDI	Class II	Active
HydraLok	PS60040R	FDA UDI	Class II	Active
ORIA™ CLARIS Spinal Clip System	2T10-6V40	FDA UDI	Class II	Active
Oracle Expandable Reactor System	500-9298	FDA UDI	Class I	Active
ORIA™ Spinal Clip System	2T10-BD525	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT60-6560	FDA UDI	Class II	Active
Ascendant PC	05-090-30-1407	FDA UDI	Class II	Active
Gibralt	05-004-00-3242	FDA UDI	Class II	Active
Octane T	600-9107	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	J072-42302019	FDA UDI	Class I	Active

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