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
BLACKBIRD Spinal System	LT21-4020	FDA UDI	Class II	Active
Ascendant PC	05-090-31-1807	FDA UDI	Class II	Active
ORIA™ CLARIS Spinal Clip System	2T46-P090	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT50-4565	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT30-65110	FDA UDI	Class II	Active
Tiger Shark System	S-PT50-A2406	FDA UDI	Class II	Active
Tiger Shark System	S-VT12-55220015	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	SPCL-P065	FDA UDI	Class I	Active
ORIA™ Spinal Clip System	2T10-BD430	FDA UDI	Class II	Active
Tiger Shark System	S-VT12-45220008	FDA UDI	Class II	Active
Tiger Shark System	S-PT46-28126	FDA UDI	Class II	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-14160845	FDA UDI	Class II	Active
Tomcat Cervical Spinal System	S-RH20-1412506	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP40-38270814	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	20-2572	FDA UDI	Class I	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MC20-S430	FDA UDI	Class II	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-1416007	FDA UDI	Class I	Active
Acapella One	05-099-29-1410	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP30-34250610	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-34251219	FDA UDI	Class I	Active
ORIA XENA® Top Clip System	CT10-BP630	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MC40-P045	FDA UDI	Class II	Active
HARPOON™ Lumbar Spacer System	PP40-28080	FDA UDI	Class II	Active
FALCON™ Anterior Cervical Plate	FT10-BF412	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT60-4540	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MC20-P090	FDA UDI	Class II	Active
Octane Straight	05-079-05-0000	FDA UDI	Class I	Active
BLACKHAWK Cervical Spacer System	S-TT10-1412606	FDA UDI	Class II	Active
TiGer Shark C	D070-0012	FDA UDI	Class I	Active
THUNDERBOLT Minimally Invasive Pedicle Screw System	M070-0129	FDA UDI	Class I	Active
HARRIER-SA Lumbar Interbody System	S-YT10-28361013	FDA UDI	Class II	Active
Oracle Expandable Reactor System	500-9604	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	ET50-6570	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT50-7570	FDA UDI	Class II	Active
Tiger Shark System	S-PT35-2408L	FDA UDI	Class II	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-14160814	FDA UDI	Class II	Active
Octane T	600-9172	FDA UDI	Class I	Active
THUNDERBOLT™ Minimally Invasive and LANCER™ Open Pedicle Screw System	M070-D008	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P072-28074	FDA UDI	Class I	Active
SHARK™ Lumbar Spacer System	PP22-22090	FDA UDI	Class II	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MC20-S170	FDA UDI	Class II	Active
Blackbird HLS	L070-1011	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-2210	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P072-28094	FDA UDI	Class I	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MT10-5545	FDA UDI	Class II	Active
STEALTH™ Anterior Cervical Interbody Spacer	DP10-1214008	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-20170	FDA UDI	Class II	Active
TOMCAT Cervical Spinal System	S-RH30-1618810	FDA UDI	Class II	Active
Acapella One	05-099-28-1406	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	RH30-1618009	FDA UDI	Class II	Active

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