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CORELINK LLC

Last updated May 24, 2026

What CORELINK LLC makes

CoreLink LLC manufactures spinal fixation devices, including non-sterile and sterile bone-screw systems for internal spinal stabilization, non-bioabsorbable spinal plates, and metallic and polymeric interbody fusion cages. Their portfolio also covers orthopaedic bone screws designed for non-sliding applications, as well as lateral screws and 3D lateral cages for spinal support.

All listed devices fall under FDA Class II regulation and are recorded 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 CoreLink LLC manufacture?

CoreLink LLC specializes in spinal fixation devices. Their portfolio includes bone-screw systems for internal spinal stabilization (both non-sterile and sterile), non-bioabsorbable spinal plates, metallic and polymeric interbody fusion cages, and orthopaedic bone screws designed for non-sliding applications. These devices are primarily used to support and stabilize the spine during surgical procedures.

Where is CoreLink LLC based?

CoreLink LLC is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites may vary.

Which regulatory registries list CoreLink LLC’s devices?

CoreLink LLC’s devices are recorded in the FDA’s Unique Device Identifier (UDI) database. This registry tracks Class II devices, which include all of CoreLink’s listed products, ensuring traceability and compliance with U.S. regulatory requirements.

How are CoreLink LLC’s devices classified under FDA regulations?

CoreLink LLC’s devices fall under FDA Class II classification. This classification applies to moderate-risk medical devices that require special controls to ensure safety and effectiveness, such as spinal fixation systems and interbody fusion cages.

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

Information

Country: US
Address: —
Website: corelinksurgical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(314)863-5401
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 064191453

Catalogue (3588)

Page 14 of 72

Device	Model / Reference	Registries	Class	Status
TIGER Spine System	61175-50	FDA UDI	Class II	Active
FOUNDATION System	830845-08	FDA UDI	Class II	Active
TIGER Spine OCT System	35845-10	FDA UDI	Class II	Active
FOUNDATION System	MA0714	FDA UDI	Class II	Active
ANODYNE Plate System	20445-16	FDA UDI	Class II	Active
TIGER Spine System	77685-90	FDA UDI	Class II	Active
TIGER Spine OCT System	TC3517-28	FDA UDI	Class II	Active
TIGER Spine System	61075-50	FDA UDI	Class II	Active
TIGER Spine System	61055-35	FDA UDI	Class II	Active
TIGER Spine System	R5505-140	FDA UDI	Class II	Active
TIGER Spine OCT System	R3502-085	FDA UDI	Class II	Active
TIGER Spine System	55865-35	FDA UDI	Class II	Active
FOUNDATION System	SA0715	FDA UDI	Class II	Active
FOUNDATION System	840050-12	FDA UDI	Class II	Active
TIGER Spine System	77365-60	FDA UDI	Class II	Active
TIGER Spine System	77665-40	FDA UDI	Class II	Active
TIGER Spine System	R5504-065	FDA UDI	Class II	Active
FOUNDATION System	PS2209	FDA UDI	Class II	Active
TIGER Spine System	77605-100	FDA UDI	Class II	Active
TIGER Spine OCT System	35635-35	FDA UDI	Class II	Active
TIGER Spine OCT System	35150-10	FDA UDI	Class II	Active
CoreLink 3D Lateral Cage	3LL1860-3020	FDA UDI	Class II	Active
ANODYNE Plate System	20001-012	FDA UDI	Class II	Active
FOUNDATION System	SAT1309	FDA UDI	Class II	Active
FOUNDATION System	SA1317	FDA UDI	Class II	Active
TIGER Spine System	77565-40	FDA UDI	Class II	Active
CoreLink 3D Lateral Cage	3LL2260-2514	FDA UDI	Class II	Active
CoreLink LATERAL PLATE	900315-22	FDA UDI	Class II	Active
FOUNDATION System	830040-08	FDA UDI	Class II	Active
TIGER Spine OCT System	R3513-100	FDA UDI	Class II	Active
TIGER Spine System	61155-50	FDA UDI	Class II	Active
CoreLink LATERAL PLATE	900115-26	FDA UDI	Class II	Active
TIGER Spine OCT System	35940-22	FDA UDI	Class II	Active
ZOU Plate System	10000-015	FDA UDI	Class II	Active
ANODYNE Plate System	21146-12	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS2735-1519	FDA UDI	Class II	Active
ANODYNE Plate System	20440-15	FDA UDI	Class II	Active
ANODYNE Plate System	21152-14	FDA UDI	Class II	Active
FLXfit 15	AT4013	FDA UDI	Class II	Active
TIGER Spine OCT System	35940-28	FDA UDI	Class II	Active
TIGER Spine System	R5504-130	FDA UDI	Class II	Active
CoreLink 3D Lateral Cage	3LL1845-2518	FDA UDI	Class II	Active
TIGER Spine System	R5508-035	FDA UDI	Class II	Active
FOUNDATION System	860025-09	FDA UDI	Class II	Active
TIGER Spine System	77595-80	FDA UDI	Class II	Active
TIGER Spine System	61055-25	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS2740-2014	FDA UDI	Class II	Active
CoreLink 3D Lateral Cage	3LL1860-2514	FDA UDI	Class II	Active
FOUNDATION System	870035-14	FDA UDI	Class II	Active
TIGER Spine System	R5509-060	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 (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

CoreLink LLC has one FDA recall record initiated on 2022-10-20, which is marked as terminated. The recall pertains to specific lots of FLXfit implants, where the manufacturer identified that internal components may have been manufactured using stainless steel instead of the stated titanium alloy.

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
Oct 20, 2022	Z-0954-2023	—	terminated	Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.