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	S-PT50-A2808	FDA UDI	Class II	Active
LANCER Pedicle Screw System	MT31-6535	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-34250614	FDA UDI	Class I	Active
Ambassador Cervical Plate System	05-109-08-0000	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	E070-0057	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-1616012	FDA UDI	Class I	Active
Choice Spine SPITFIRE Retractor	M070-1005	FDA UDI	Class I	Active
Tiger Shark System	S-VT12-60170015	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-240612	FDA UDI	Class II	Active
ORIA XENA® Top Clip System	CT60-TL02	FDA UDI	Class II	Active
Gibralt	05-000-07-4514	FDA UDI	Class II	Active
Ascendant	05-090-11-1404	FDA UDI	Class II	Active
Octane Straight	05-071-03-2411	FDA UDI	Class II	Active
Thunderbolt	MT11-4550-080	FDA UDI	Class II	Active
Acapella One	05-099-11-0003	FDA UDI	Class I	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-14160824	FDA UDI	Class II	Active
TOMCAT™ Cervical Spinal System	R070-1616409	FDA UDI	Class I	Active
TOMCAT Cervical Spinal System	S-RH30-1412007	FDA UDI	Class II	Active
TiGER SHARK Interbody Fusion System	D070-DS614120910	FDA UDI	Class II	Active
Tiger Shark System	S-PT34-24140	FDA UDI	Class II	Active
LANCER Pedicle Screw System	MT30-12575	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	20-2228	FDA UDI	Class I	Active
TYPHOON™Facet Screw Fixation System	K070-0012	FDA UDI	Class I	Active
ORIA™ CLARIS Spinal Clip System	2T10-7V70	FDA UDI	Class II	Active
Tigershark	P070-T281106	FDA UDI	Class II	Active
Silverbolt/Mainframe	200-0675	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	20-3142	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	V070-0057	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	RH20-1614007	FDA UDI	Class II	Active
TYPHOON™Facet Screw Fixation System	K070-SD4520	FDA UDI	Class I	Active
HARRIER-SA Lumbar Interbody System	S-YP10-26321517	FDA UDI	Class II	Active
SHARK Lumbar Spacer System	PT22-28174	FDA UDI	Class II	Active
Ambassador Cervical Plate System	05-109-22-2322	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	22-0587	FDA UDI	Class I	Active
THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems	MC20-P100	FDA UDI	Class II	Active
Octane Straight	05-071-01-3214	FDA UDI	Class II	Active
Octane P	601-98-0217	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT30-4565	FDA UDI	Class II	Active
Ambassador Cervical Plate System	05-109-22-2511	FDA UDI	Class I	Active
Octane T	600-9037	FDA UDI	Class I	Active
LANCER™ Pedicle Screw System	MC40-S230	FDA UDI	Class II	Active
LANCER™/THUNDERBOLT™ Pedicle Screw System	M070-0041	FDA UDI	Class I	Active
Ascendant	05-090-11-1806	FDA UDI	Class II	Active
Gibralt	05-009-36-3228	FDA UDI	Class I	Active
Octane T	600-9813	FDA UDI	Class II	Active
Acapella One	05-099-28-1610	FDA UDI	Class I	Active
Acapella One	05-099-31-1406	FDA UDI	Class I	Active
STEALTH™ Anterior Cervical Interbody Spacer	DP20-1416008	FDA UDI	Class II	Active
VEO Lateral Interbody Fusion System	V070-B121717	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	RH20-1614806	FDA UDI	Class II	Active

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