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SPINAL ELEMENTS, INC.

Last updated September 17, 2026

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 1 of 267

Device	Model / Reference	Registries	Class	Status
Talon	RTS08070	FDA UDI	Class II	Active
Overwatch	108-ET-7565DC	FDA UDI	Class II	Active
Zeus-T	67-361115	FDA UDI	Class II	Active
Ventana P/T	41100-000	FDA UDI	Class I	Active
Talon	T70120	FDA UDI	Class II	Active
Sapphire	26005-095	FDA UDI	Class II	Active
Lucent L	11852-212	FDA UDI	Class I	Active
Bone Graft Delivery	11377-302	FDA UDI	Class I	Active
Lucent L	81143-170	FDA UDI	Class I	Active
Magnum+	15010-000	FDA UDI	Class I	Active
Overwatch	AISB-0019AR	FDA UDI	Class I	Active
Overwatch	108-RS-5550	FDA UDI	Class II	Active
Overwatch	108-327-015	FDA UDI	Class I	Active
Lucent L	11075-890	FDA UDI	Class I	Active
Lucent L	P10001-000-62	FDA UDI	Class I	Active
Vertu	53036-018	FDA UDI	Class I	Active
Zeus-O	10101-1130	FDA UDI	Class I	Active
Zeus-P	SP-0488-13	FDA UDI	Class I	Unknown
Overwatch	108-RS-7560D	FDA UDI	Class II	Active
Zeus-P	1-140926B	FDA UDI	Class II	Active
Ventana L	42245-612	FDA UDI	Class II	Active
Ventana C	42016-112	FDA UDI	Class II	Active
Lotus	32156-000	FDA UDI	Class I	Active
Overwatch	108-805	FDA UDI	Class I	Active
Zeus-L	16-1112	FDA UDI	Class I	Unknown
Zeus-L	62-142360-14	FDA UDI	Class II	Active
Vertu	53022-020	FDA UDI	Class I	Active
Lucent L	11852-206	FDA UDI	Class I	Active
Savannah-T	11000-44	FDA UDI	Class I	Active
Lotus	32325-000	FDA UDI	Class II	Active
Pathway	070012	FDA UDI	Class II	Unknown
Ventana L	41855-210	FDA UDI	Class II	Active
Mosaic	25040-018	FDA UDI	Class II	Unknown
Crystal	21411-713	FDA UDI	Class II	Active
Savannah-T	10-21-7540-1	FDA UDI	Class II	Active
Sapphire X	27002-028	FDA UDI	Class II	Active
Lucent L	81053-000	FDA UDI	Class I	Active
Mercury	62364-010	FDA UDI	Class II	Active
Talon	SP-0251	FDA UDI	Class I	Active
Zeus-O	10101-1426	FDA UDI	Class I	Active
Zeus-T	100C1107	FDA UDI	Class II	Active
Securis	115070	FDA UDI	Class II	Unknown
Talon	MTLT4010	FDA UDI	Class II	Active
Ventana C	40013-003	FDA UDI	Class I	Active
Ventana L	42255-207	FDA UDI	Class II	Active
Lucent L	P11860-213	FDA UDI	Class II	Active
Phenix	8178-1714-7P	FDA UDI	Class I	Unknown
Diamond	10003-V-4014	FDA UDI	Class II	Unknown
Ventana L	42255-212	FDA UDI	Class II	Active
Ventana P/T	41032-512	FDA UDI	Class II	Active

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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.

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.