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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 4 of 267

Device	Model / Reference	Registries	Class	Status
Lucent	10091-000	FDA UDI	Class I	Active
Lucent L	81069-000	FDA UDI	Class II	Unknown
Ceres	12-155-5016	FDA UDI	Class II	Active
Venus	VCP377	FDA UDI	Class II	Unknown
Lucent L	12242-613	FDA UDI	Class I	Active
Mercury	61230-000	FDA UDI	Class I	Active
Magnum+	P14127-217	FDA UDI	Class II	Active
Vertu	53016-003	FDA UDI	Class I	Active
Mercury	63565-085	FDA UDI	Class II	Active
Overwatch	108-327-031	FDA UDI	Class I	Active
Magnum+	15002-000-20	FDA UDI	Class I	Active
Mercury	60106-012	FDA UDI	Class II	Active
Savannah-T	29-1-4045	FDA UDI	Class II	Active
Sapphire X3	27235-014	FDA UDI	Class II	Active
Luna Xd	IBS6114	FDA UDI	Class I	Active
Vertu	53013-001	FDA UDI	Class I	Active
Lucent L	11941-264	FDA UDI	Class I	Active
Savannah-T	10-03-5535-2	FDA UDI	Class II	Active
Dimension	11075-380	FDA UDI	Class I	Active
Vertu	53022-015	FDA UDI	Class I	Active
Crystal	20015-706	FDA UDI	Class I	Active
Lucent	81101-001	FDA UDI	Class II	Active
Incorporate	SP-0584-1714-28-10	FDA UDI	Class I	Active
Lucent	11004-516	FDA UDI	Class I	Active
Lucent L	81066-025	FDA UDI	Class I	Active
Mercury	63085-040	FDA UDI	Class II	Active
Ceres-C	08-170-0908	FDA UDI	Class II	Active
Phenix	8178-5-07P	FDA UDI	Class I	Unknown
Savannah	10-02-6550-5	FDA UDI	Class II	Active
Ventana L	42250-810	FDA UDI	Class II	Active
Sapphire X3	27135-016	FDA UDI	Class II	Active
Vertu	53007-019	FDA UDI	Class I	Active
Magnum+	15001-000-75	FDA UDI	Class I	Active
Pathway	142812	FDA UDI	Class II	Unknown
Lucent	11011-511	FDA UDI	Class I	Active
Talon	RTS05050	FDA UDI	Class II	Active
Magnum+	15016-019	FDA UDI	Class I	Active
Overwatch	108-IC-85110	FDA UDI	Class II	Active
Mercury	63575-085	FDA UDI	Class II	Active
Mercury	63495-120	FDA UDI	Class II	Active
Overwatch	2TMD3	FDA UDI	Class I	Active
Zeus-T	67-03-10	FDA UDI	Class I	Active
Phenix	9000-1F-5P	FDA UDI	Class I	Unknown
Syzygy	85-6540-2	FDA UDI	Class II	Active
Overwatch	108-RS-5530D	FDA UDI	Class II	Active
Ceres-C	08-171-0909	FDA UDI	Class II	Active
Zeus-L	62-182150-07	FDA UDI	Class II	Active
Lucent L	11075-880	FDA UDI	Class I	Active
Amendia	10-06-6550-2	FDA UDI	Class II	Active
Lucent L	11843-616	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

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Importers

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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.