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SeaSpine Orthopedics Corporation

Last updated September 17, 2026

Information

Country: US
Address: 5770 Armada Dr, Carlsbad, CA, 92008
Website: www.seaspine.com
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3012120772
DUNS Number: —

Catalogue (21840)

Page 1 of 437

Device	Model / Reference	Registries	Class	Status
Meridian	RA1-101620	FDA UDI	Class II	Active
Mariner MCT	MC2-003035	FDA UDI	Class I	Active
VuMesh	15-40-0800	FDA UDI	Class I	Active
Coral	10-40-0310	FDA UDI	Class I	Active
Zuma™	95-5230	FDA UDI	Class II	Active
Sonoma™	23-8012	FDA UDI	Class II	Active
Stainless Steel	25-34-4060	FDA UDI	Class II	Active
Ventura NanoMetalene System	93-3705	FDA UDI	Class II	Active
Cordant	26-99-0001-3	FDA UDI	Class I	Active
SeaSpine® Spacer System - Redondo	93-6505	FDA UDI	Class I	Active
SeaSpine Spacer System - Hollywood™	34-8013	FDA UDI	Class II	Active
Mariner	41-6035-4	FDA UDI	Class II	Active
Malibu	13-8005	FDA UDI	Class II	Unknown
Vu ePOD™	14-26-2616	FDA UDI	Class II	Active
Vu cPOD™	11-12-0205	FDA UDI	Class II	Active
Cambria NanoMetalene	39-2605-S	FDA UDI	Class II	Active
NorthStar	PC1-514055	FDA UDI	Class II	Active
Mariner MCT	MC2-001050	FDA UDI	Class I	Active
Mariner Cortical	MC1-090100	FDA UDI	Class II	Unknown
Mariner Cortical	MC1-185030	FDA UDI	Class II	Unknown
Laminoplasty	95-2207	FDA UDI	Class I	Active
Specials	SR-0827-02	FDA UDI	Class I	Active
Manta Ray	22-40-0325	FDA UDI	Class I	Active
Disc Prep	06-45-0214	FDA UDI	Class I	Active
Disc Prep	06-35-0314	FDA UDI	Class I	Active
SeaSpine Spacer System - Ventura™ NanoMetalene®	93-3824	FDA UDI	Class II	Active
SeaSpine Spacer System - Ventura™	93-3377	FDA UDI	Class II	Active
Stainless Steel	25-10-8535	FDA UDI	Class II	Active
Reef TA	TA1-132160	FDA UDI	Class II	Active
Mariner Cortical	MC1-195100	FDA UDI	Class II	Active
NewPort	91-8613	FDA UDI	Class I	Active
NorthStar	PC1-714009	FDA UDI	Class II	Active
Reef L	RL2-285515	FDA UDI	Class I	Active
Mariner Cortical	MC1-010090	FDA UDI	Class II	Active
Mariner Cortical	MC1-155085	FDA UDI	Class II	Unknown
Zuma-L™	56-9012	FDA UDI	Class II	Active
Specials	SR-0915	FDA UDI	Class I	Active
Vu a-POD Prime™	33-15-6525	FDA UDI	Class II	Active
Specials	SR-1092-35	FDA UDI	Class I	Active
Specials	SR-0446-01	FDA UDI	Class I	Active
WaveForm™ C	AC1-285057	FDA UDI	Class II	Active
Daytona	97-6220	FDA UDI	Class II	Active
Shoreline ACS	85-0309	FDA UDI	Class II	Active
SeaSpine Spacer System - Ventura™	93-3204	FDA UDI	Class II	Active
Coral	10-11-7545	FDA UDI	Class II	Unknown
Lateral Retractor	95-6894	FDA UDI	Class I	Active
Anterior Disc Prep	95-6197	FDA UDI	Class I	Active
Meridian	RA2-141410	FDA UDI	Class I	Active
Cambria™ NanoMetalene®	93-9859	FDA UDI	Class II	Active
SeaSpine Spacer System - Hollywood™	93-4186	FDA UDI	Class II	Active

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FDA Recalls (9)

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
Nov 17, 2025	Z-0937-2026	—	open, classified	The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments. However, the NorthStar OCT Navigation Instruments are compatible for use with Medtronic s Solera toolcards only.
Aug 6, 2025	Z-2554-2025	—	open, classified	Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking.
Oct 29, 2024	Z-0752-2025	—	open, classified	Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
Oct 29, 2024	Z-0751-2025	—	open, classified	Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
Jun 4, 2024	Z-2357-2024	—	open, classified	Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
May 17, 2024	Z-2234-2024	—	open, classified	Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
May 17, 2024	Z-2235-2024	—	open, classified	Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
Feb 28, 2024	Z-1620-2024	—	open, classified	Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
Feb 15, 2024	Z-1605-2024	—	open, classified	Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.