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
VEO® Lateral Interbody Fusion System	22-0546-10	FDA UDI	Class I	Active
ORIA XENA® Top Clip System	CT10-BP760	FDA UDI	Class II	Active
Octane Straight PC	05-072-01-2413	FDA UDI	Class II	Active
Dynabolt	300-4290	FDA UDI	Class II	Active
Octane M	05-041-05-2607	FDA UDI	Class II	Active
HydraLok	PS75045	FDA UDI	Class II	Active
Tigershark	P070-T321306	FDA UDI	Class I	Active
Blackbird HLS	L070-1001	FDA UDI	Class II	Active
Silverbolt/Mainframe	200-5735	FDA UDI	Class II	Active
STARFIRE™ Pedicle Screw System	ET30-5045	FDA UDI	Class II	Active
Dynabolt	300-4255	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	22-0384	FDA UDI	Class I	Active
VEO Lateral Interbody Fusion System	V070-61713P	FDA UDI	Class II	Active
HAWKEYE Vertebral Body Replacement (VBR)	WT10-12140037	FDA UDI	Class II	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-34251216	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-N0002	FDA UDI	Class I	Active
BLACKHAWK Cervical Spacer System	S-TT10-1412607	FDA UDI	Class II	Active
VEO® Lateral Interbody Fusion System	22-0469-19	FDA UDI	Class II	Active
HARRIER-SA Lumbar Interbody System	S-YP10-30403021	FDA UDI	Class II	Active
STEALTH™ Anterior Cervical Interbody Spacer	DP20-1416010	FDA UDI	Class II	Active
SCS CLARIS Spinal Screws	2T10E5-40	FDA UDI	Class II	Active
LANCER™ Pedicle Screw System	MT40-H130	FDA UDI	Class II	Active
FALCON™ Anterior Cervical Plate	A070-0028	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	E070-0044	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	ET50-85110	FDA UDI	Class II	Active
BLACKBIRD™ Spinal System	L070-0060	FDA UDI	Class I	Active
Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)	P070-6003	FDA UDI	Class I	Active
HARRIER-SA Lumbar Interbody System	YT30-5060	FDA UDI	Class II	Active
BLACKBIRD Spinal System	LT11-4526	FDA UDI	Class II	Active
Tiger Shark System	S-VT12-65220009	FDA UDI	Class II	Active
Silverbolt/Mainframe	200-2055	FDA UDI	Class II	Active
LANCER Pedicle Screw System	MT31-5555	FDA UDI	Class II	Active
Tiger Shark	P070-1016	FDA UDI	Class I	Active
LANCER/THUNDERBOLT Pedicle Screw System	M070-KTN220	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-N1614512	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-1618409	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	R070-1412411	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	20-3022	FDA UDI	Class I	Active
VEO® Lateral Interbody Fusion System	V070-0032	FDA UDI	Class I	Active
STARFIRE™ Pedicle Screw System	E070-0001	FDA UDI	Class I	Active
ORIA™ Spinal Clip System	2T10-BD830	FDA UDI	Class II	Active
Thunderbolt	MT11-4575-080	FDA UDI	Class II	Active
LANCER/THUNDERBOLT Pedicle Screw System	M070-KTS222	FDA UDI	Class I	Active
Acapella One	05-099-11-0001	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-42301213	FDA UDI	Class I	Active
STEALTH™ Anterior Cervical Interbody Spacer	D070-CN1214605	FDA UDI	Class I	Active
HARRIER™ Choice Spine Intervertebral Body Device	J071-34250017	FDA UDI	Class I	Active
TOMCAT™ Cervical Spinal System	SPCL-R1412405	FDA UDI	Class I	Active
Navigation	NV70-L016	FDA UDI	Class I	Active
Thunderbolt	MT11-7550-080	FDA UDI	Class II	Active

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