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SeaSpine Orthopedics Corporation

Last updated September 17, 2026

What SeaSpine Orthopedics Corporation makes

The company manufactures spinal fixation devices, including non-bioabsorbable bone screws, metal-polymer composite interbody fusion cages, and reusable instrument trays and bone taps. Their portfolio also includes spinal implant trials, non-sterile vertebral body prostheses, and spinal fixation plates. Specific products include systems like the Ventura NanoMetalene, Cordant, and branded implants such as the Meridian, Mariner, and Coral.

These devices are regulated under FDA classification as Class I, Class II, and Unclassified (U), with entries 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 SeaSpine Orthopedics Corporation manufacture?

SeaSpine Orthopedics Corporation specializes in spinal fixation devices. Their portfolio includes non-bioabsorbable spinal bone screws, metal-polymer composite spinal interbody fusion cages, reusable instrument trays and bone taps, spinal implant trials, non-sterile vertebral body prostheses, and spinal fixation plates. These devices are designed to support spinal stability and fusion procedures.

Where is SeaSpine Orthopedics Corporation based?

SeaSpine Orthopedics Corporation is headquartered in the United States. The company’s location influences its regulatory compliance, particularly with the FDA, which oversees medical device authorization in the US.

Which regulatory registries list SeaSpine Orthopedics Corporation’s devices?

SeaSpine Orthopedics Corporation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the US, ensuring transparency and traceability for healthcare providers and regulators.

How are SeaSpine Orthopedics Corporation’s devices classified by the FDA?

SeaSpine Orthopedics Corporation’s devices fall under three FDA classification categories: Class I (generally low-risk devices), Class II (devices requiring special controls to ensure safety and effectiveness), and Unclassified (U) devices, which may require additional evaluation. Classification determines the regulatory pathway for authorization, with higher-risk devices requiring more stringent scrutiny.

What distinguishes SeaSpine Orthopedics Corporation’s spinal fixation devices from others?

SeaSpine’s devices include a mix of reusable and single-use components, such as reusable instrument trays and bone taps alongside non-bioabsorbable implants like screws and plates. They also feature proprietary systems like the Ventura NanoMetalene and branded implants (e.g., Meridian, Coral), which combine materials like metal-polymer composites for spinal fusion. These innovations aim to enhance stability and surgical precision in spinal procedures.

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

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 2 of 437

Device	Model / Reference	Registries	Class	Status
Mariner Cortical	MC1-080025	FDA UDI	Class II	Unknown
Mariner Cortical	MC1-055050	FDA UDI	Class II	Unknown
Reef TH	TH3-009002	FDA UDI	Class I	Active
Reef TO	TO1-128125	FDA UDI	Class II	Active
Laminoplasty	52-1214	FDA UDI	Class II	Active
Atoll™	16-21-1806	FDA UDI	Class II	Active
VuMesh™	15-10-1470	FDA UDI	Class II	Active
Mariner Cortical	MC1-200090	FDA UDI	Class II	Active
Shoreline RT	85-6511	FDA UDI	Class II	Active
Daytona Small Stature	76-0165	FDA UDI	Class II	Active
Cambria™	93-9132	FDA UDI	Class II	Active
Stainless Steel	25-26-3000	FDA UDI	Class II	Active
Manta Ray™	22-20-0363	FDA UDI	Class II	Active
Regatta	36-180855-00	FDA UDI	Class II	Active
Daytona Small Stature	97-6329	FDA UDI	Class I	Active
SeaSpine® Spacer System - Redondo	93-6506	FDA UDI	Class I	Active
Meridian	RA1-250416	FDA UDI	Class II	Active
Cordant	26-07-0246	FDA UDI	Class II	Active
Reef TH	TH1-132132	FDA UDI	Class II	Active
SeaSpine Spacer System - Pacifica™	93-3247	FDA UDI	Class II	Active
Lateral Retractor	95-6943	FDA UDI	Class I	Active
NorthStar	PC1-314038	FDA UDI	Class II	Active
3D Printed Interbody System	WA4-111410	FDA UDI	Class II	Active
SeaSpine Expandable Interbody	82-2710	FDA UDI	Class II	Active
Coral	10-40-0131-45	FDA UDI	Class I	Active
Atoll	16-32-4513	FDA UDI	Class II	Active
Coral	18-14-4530	FDA UDI	Class II	Active
SeaSpine Spacer System - Pacifica™	93-3316	FDA UDI	Class II	Active
Mariner Outrigger	99-1051-160-12	FDA UDI	Class II	Active
Disc Prep	06-35-0001	FDA UDI	Class I	Active
Coral	10-11-5540	FDA UDI	Class II	Unknown
Malibu	16-0010	FDA UDI	Class II	Active
Mariner	41-1030-4	FDA UDI	Class II	Active
WaveForm™ L	WL1-144515	FDA UDI	Class II	Active
Mariner Cortical	MC1-060030	FDA UDI	Class II	Unknown
Reef TO	TO2-128094	FDA UDI	Class I	Active
Malibu	68-6545	FDA UDI	Class II	Unknown
Vu cPOD™	11-43-0206	FDA UDI	Class II	Unknown
Coral	10-24-1420	FDA UDI	Class II	Active
Malibu	15-7555	FDA UDI	Class II	Active
Reef TO	TO1-924112	FDA UDI	Class II	Active
Admiral	AP1-714017	FDA UDI	Class II	Active
SeaSpine Spacer System - Pacifica	93-3480	FDA UDI	Class I	Active
Shoreline™ ACS	85-0807-S	FDA UDI	Class II	Active
SeaSpine Spacer System - Pacifica™	93-3100	FDA UDI	Class II	Unknown
Malibu	13-5535	FDA UDI	Class II	Active
Mariner	41-4775-2	FDA UDI	Class II	Active
Vu aPod™ - L	31-25-1460-12	FDA UDI	Class II	Active
Cabo	81-0120	FDA UDI	Class II	Active
Specials	SR-1108-10	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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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.

SeaSpine Orthopedics Corporation has initiated nine recall records between February 15, 2024, and November 17, 2025. The records include both open and classified statuses, with reasons involving compatibility misidentifications, manufacturing defects in locking caps and screw heads, potential intraoperative complications from inserters and weld deficiencies, and incorrect blade manufacturing that may affect bone integrity.

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
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.