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SPINAL ELEMENTS, INC.

Last updated September 17, 2026

What SPINAL ELEMENTS, INC. makes

Spinal Elements, Inc. manufactures reusable orthopaedic instruments for spinal prosthesis implantation, including bone-screw internal spinal fixation systems and sterilization/disinfection containers. Their product portfolio also includes spinal interbody fusion cages—polymeric, metal-polymer composite, and metallic—and non-bioabsorbable spinal fixation plates.

These devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Spinal Elements, Inc. manufacture?

Spinal Elements, Inc. specializes in devices primarily used for spinal surgery and orthopaedic applications. Their product line includes reusable orthopaedic instruments like bone-screw internal spinal fixation systems and sterilization/disinfection containers. They also produce spinal interbody fusion cages—available in polymeric, metal-polymer composite, and metallic versions—as well as non-bioabsorbable spinal fixation plates. These devices support spinal stabilization and fusion procedures.

Where is Spinal Elements, Inc. based?

Spinal Elements, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution, particularly for FDA-related processes.

Which regulatory registries or databases list Spinal Elements, Inc.’s devices?

Spinal Elements, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, regulators, and other stakeholders by assigning a unique identifier to each device type.

How are Spinal Elements, Inc.’s devices classified under FDA regulations?

Spinal Elements, Inc.’s devices fall under FDA’s Class I and Class II categories. Class I generally includes low-risk devices requiring general controls, while Class II devices involve special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, risk level, and potential impact on patient health.

What is the purpose of the reusable orthopaedic instruments manufactured by Spinal Elements, Inc.?

The reusable orthopaedic instruments, such as bone-screw internal spinal fixation systems and sterilization/disinfection containers, are designed to assist surgeons in positioning spinal prostheses accurately during implantation procedures. These tools enhance precision, reduce surgical time, and contribute to better clinical outcomes by ensuring proper alignment and fixation of spinal components.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: 3115 Melrose Dr Suite 200, CARLSBAD, CA, 92010
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3004893332
DUNS Number: —

Catalogue (13338)

Page 5 of 267

Device	Model / Reference	Registries	Class	Status
Mercury	60100-030	FDA UDI	Class II	Active
Zeus-P	PH251316	FDA UDI	Class II	Unknown
Talon	MT83545	FDA UDI	Class II	Active
Securis	115045	FDA UDI	Class II	Unknown
Phenix	10201-141224L	FDA UDI	Class II	Unknown
Overwatch	108-HXRD-300	FDA UDI	Class II	Active
Lucent L	11076-240	FDA UDI	Class I	Active
Ventana C	42014-706	FDA UDI	Class II	Active
Mercury	62210-105	FDA UDI	Class II	Active
Luna Xd	LUN26012-14	FDA UDI	Class I	Active
Magnum+	15027-813	FDA UDI	Class I	Active
Ventana L	41855-607	FDA UDI	Class II	Active
Lucent L	81179-170	FDA UDI	Class I	Active
Lucent L	80503-002	FDA UDI	Class I	Active
Magnum+	15105-000	FDA UDI	Class I	Active
Vertu	52008-000	FDA UDI	Class I	Active
Crystal	20014-009	FDA UDI	Class I	Active
Lucent Xp	11362-000	FDA UDI	Class I	Active
Lucent-L	11824-602	FDA UDI	Class I	Unknown
Sapphire	26240-016	FDA UDI	Class II	Active
Prone Lateral	89002-170	FDA UDI	Class I	Active
Crystal	20015-712	FDA UDI	Class I	Active
Prone Lateral	89001-170	FDA UDI	Class I	Active
Lucent L	80105-080	FDA UDI	Class I	Active
Mercury	62555-075	FDA UDI	Class II	Active
Mercury	61003-000-07	FDA UDI	Class I	Active
Crystal	20015-009L	FDA UDI	Class I	Active
Magnum+	15727-618	FDA UDI	Class I	Active
Bone Graft Delivery	11372-007	FDA UDI	Class I	Active
Magnum+	15026-215	FDA UDI	Class I	Active
Lucent L	11066-208	FDA UDI	Class I	Active
Lucent	10005-007	FDA UDI	Class I	Active
Mercury	62365-030	FDA UDI	Class II	Active
Lucent L	P12240-210	FDA UDI	Class II	Active
Crystal	21414-008	FDA UDI	Class II	Active
Vertu	P52412-708	FDA UDI	Class II	Active
Lotus	31117-035	FDA UDI	Class II	Active
Omni	T04040	FDA UDI	Class II	Active
Ceres-C	08-171-0506	FDA UDI	Class II	Active
Mercury	62125-000	FDA UDI	Class I	Active
Mercury	61031-065	FDA UDI	Class I	Active
Lotus	32540-012	FDA UDI	Class II	Active
Mercury	63275-050	FDA UDI	Class II	Active
Lucent L	12220-612	FDA UDI	Class I	Active
Crystal	20010-000	FDA UDI	Class I	Active
Lucent L	11804-618	FDA UDI	Class I	Active
Lucent	P13025-015	FDA UDI	Class II	Active
Diamond	6-2-54	FDA UDI	Class II	Unknown
Lucent L	11941-464	FDA UDI	Class I	Active
Overwatch	108-328-002	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

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FDA Recalls (24)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Spinal Elements, Inc. has 24 recall records listed in the FDA database, initiated between April 17, 2009, and April 16, 2018. The recalls include open, classified, and terminated statuses, with reasons involving unsubstantiated or misleading literature regarding a coating, incorrect labeling of lordosis degrees on implants, traceability issues with missing or improperly marked product identification numbers on rods, and a raw material issue with the Mercury Spinal System.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Apr 16, 2018	Z-1912-2018	—	open, classified	Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis.
Apr 9, 2015	Z-1597-2015	—	terminated	Some rods may not meet the appropriate traceability requirements including the lot number. Some rods were found to not include the product identification number (product number and lot number) marked directly on the rod. The lack of marking interrupts the ability to maintain traceability of the device.
Dec 18, 2014	Z-0907-2015	—	terminated	Spinal Elements is recalling the Ti-Bond related brochures that includes LT-10000 and MP-14000 (all revisions) the content regarding the Ti-Bond coating within the literature is unsubstantiated in context and/or misleading for the coating's use in spine applications.
Apr 17, 2009	Z-1253-2013	—	terminated	Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Apr 17, 2009	Z-1264-2013	—	terminated	Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Apr 17, 2009	Z-1254-2013	—	terminated	Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Apr 17, 2009	Z-1255-2013	—	terminated	Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Apr 17, 2009	Z-1249-2013	—	terminated	Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Apr 17, 2009	Z-1266-2013	—	terminated	Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Apr 17, 2009	Z-1259-2013	—	terminated	Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Apr 17, 2009	Z-1246-2013	—	terminated	Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Apr 17, 2009	Z-1260-2013	—	terminated	Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Apr 17, 2009	Z-1256-2013	—	terminated	Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Apr 17, 2009	Z-1265-2013	—	terminated	Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Apr 17, 2009	Z-1252-2013	—	terminated	Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Apr 17, 2009	Z-1248-2013	—	terminated	Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Apr 17, 2009	Z-1261-2013	—	terminated	Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Apr 17, 2009	Z-1257-2013	—	terminated	Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Apr 17, 2009	Z-1263-2013	—	terminated	Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Apr 17, 2009	Z-1250-2013	—	terminated	Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Apr 17, 2009	Z-1258-2013	—	terminated	Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Apr 17, 2009	Z-1247-2013	—	terminated	Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Apr 17, 2009	Z-1262-2013	—	terminated	Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Apr 17, 2009	Z-1251-2013	—	terminated	Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.