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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 6 of 267

Device	Model / Reference	Registries	Class	Status
Mercury	63426-418	FDA UDI	Class I	Active
Mosaic	50020-000	FDA UDI	Class I	Active
Lucent L	11078-008	FDA UDI	Class I	Active
Diamond	10000-1-24	FDA UDI	Class II	Unknown
Savannah-T	10-03-5530-2	FDA UDI	Class II	Active
Ventana C	40013-006-02	FDA UDI	Class I	Active
Overwatch	108-ET-6545	FDA UDI	Class II	Active
Crystal	20028-705	FDA UDI	Class I	Active
Mercury	63420-000	FDA UDI	Class I	Active
Crystal	20025-012	FDA UDI	Class I	Active
Mercury	63215-000	FDA UDI	Class II	Active
Crystal	21111-007	FDA UDI	Class II	Active
Zeus-L	16-1128L	FDA UDI	Class I	Unknown
Overwatch	SP-0568	FDA UDI	Class I	Active
Overwatch	108-823	FDA UDI	Class I	Active
Mosaic	51415-212	FDA UDI	Class II	Unknown
Ceres	30-1011-014	FDA UDI	Class I	Active
Savannah-T	10707-055	FDA UDI	Class II	Active
Mercury	60075-050	FDA UDI	Class II	Active
Magnum+	15128-619	FDA UDI	Class I	Active
Mercury	64075-110	FDA UDI	Class II	Active
Crystal	20006-707	FDA UDI	Class I	Active
Lotus	32508-024	FDA UDI	Class II	Active
Lucent	11010-513	FDA UDI	Class I	Active
Mercury	63255-075	FDA UDI	Class II	Active
Lotus	31200-500	FDA UDI	Class II	Active
Crystal	21411-006	FDA UDI	Class II	Active
Mercury	64075-040	FDA UDI	Class II	Active
Zeus-A	ZA13422518	FDA UDI	Class II	Unknown
Savannah-T	SP-0323-D	FDA UDI	Class I	Active
Zeus-L	62-122155-07T	FDA UDI	Class I	Unknown
Sapphire X3	27081-017	FDA UDI	Class II	Active
Ventana C	40061-204	FDA UDI	Class I	Active
Mercury	62210-140	FDA UDI	Class II	Active
Mercury	63101-060	FDA UDI	Class II	Active
Overwatch	108-IL-8590	FDA UDI	Class II	Active
Zeus-T	PI-2106-299	FDA UDI	Class I	Active
Zeus-C	CLTX009	FDA UDI	Class I	Unknown
Syzygy	85-5535-2	FDA UDI	Class II	Active
Magnum+	P14127-818	FDA UDI	Class II	Active
Talon	LCT40-F	FDA UDI	Class II	Unknown
Sapphire X	27001-010	FDA UDI	Class II	Active
Omegalif	72-TR	FDA UDI	Class I	Active
Black Widow	TBS050	FDA UDI	Class II	Active
Savannah-T	10-02-7530-52	FDA UDI	Class II	Active
Overwatch	108-RS-9535	FDA UDI	Class II	Active
Lucent Xp	11367-500-02	FDA UDI	Class I	Active
Savannah-T	10-06-7545-2	FDA UDI	Class II	Active
Ventana C	42016-008	FDA UDI	Class II	Active
Ceres	12-30-1005-16	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.