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	P070-2809116	FDA UDI	Class I	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-14160047	FDA UDI	Class II	Active
Tomcat Cervical Spinal System	S-RH20-1412510	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	Y070-26321012	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP40-38271220	FDA UDI	Class II	Active
LANCER™/THUNDERBOLT™ Pedicle Screw System	M070-0064	FDA UDI	Class I	Active
Ascendant PC	05-090-30-1608	FDA UDI	Class II	Active
THUNDERBOLT Minimally Invasive Pedicle Screw System	M070-0168	FDA UDI	Class I	Active
Tigershark	P070-T250706	FDA UDI	Class II	Active
Octane Straight	05-049-20-0006	FDA UDI	Class I	Active
TOMCAT Cervical Spinal System	S-RH20-1618708	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT60-7590	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT40-S170	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET10-55110	FDA UDI	Class II	Active
Acapella One	05-099-08-0000	FDA UDI	Class I	Active
ORIA XENA® Top Clip System	CT10-BP950	FDA UDI	Class II	Active
HAWKEYE™ Vertebral Body Replacement (VBR)	DP40-1416640	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-1418	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	RH20-1618811	FDA UDI	Class II	Active
BLACKHAWK Cervical Spacer System	S-TT20-1614008	FDA UDI	Class II	Active
ORIA™ CLARIS Spinal Clip System	2T10-7V50	FDA UDI	Class II	Active
Tiger Shark System	D070-DS018150506	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-38270016	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-20184	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-6047	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP25-30222020	FDA UDI	Class II	Active
Blackbird HLS	LT50-0006	FDA UDI	Class II	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	T070-32090	FDA UDI	Class I	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MC20-P040	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-4545	FDA UDI	Class II	Active
LANCER Pedicle Screw System	MT60-105110	FDA UDI	Class II	Active
Raven Lumbar Plate System	YT50-AP22	FDA UDI	Class II	Active
Ambassador	05-100-10-4014	FDA UDI	Class II	Active
HydraLok	28223	FDA UDI	Class II	Active
Ambassador	05-100-09-4018	FDA UDI	Class II	Active
LANCER/THUNDERBOLT Pedicle Screw System	M070-0135	FDA UDI	Class I	Active
Acapella One	05-099-05-1410	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP40-38270618	FDA UDI	Class II	Active
FALCON™ Anterior Cervical Plate	FT10-BL410	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET10-5540	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	JP40-38270411	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	E070-0018	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	RH20-1618010	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT60-9565	FDA UDI	Class II	Active
Acapella One	05-099-05-1407	FDA UDI	Class I	Active
Ambassador Cervical Plate System	05-109-08-0002	FDA UDI	Class I	Active
FALCON™ Anterior Cervical Plate	SPCL-A013	FDA UDI	Class I	Active
LANCER™ Pedicle Screw System	MT30-5555	FDA UDI	Class II	Active
Tiger Shark System	P070-321406	FDA UDI	Class I	Active
VEO Lateral Interbody Fusion System	V070-A2215P	FDA UDI	Class II	Active

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