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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 32 of 72

Device	Model / Reference	Registries	Class	Status
TIGER Spine System	55475-120	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS3040-2019	FDA UDI	Class II	Active
TIGER Spine System	77875-70	FDA UDI	Class II	Active
TIGER Spine System	55345-45	FDA UDI	Class II	Active
TIGER Spine System	77585-50	FDA UDI	Class II	Active
TIGER Spine System	55265-55	FDA UDI	Class II	Active
FOUNDATION System	830860-09	FDA UDI	Class II	Active
TIGER Spine System	R55090-75	FDA UDI	Class II	Active
TIGER Spine System	55365-45	FDA UDI	Class II	Active
FOUNDATION System	SA1318	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS2735-1518	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS2740-2521	FDA UDI	Class II	Active
FOUNDATION System	PS2215	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS3045-1515	FDA UDI	Class II	Active
TIGER Spine System	55060-40	FDA UDI	Class II	Active
CoreLink 3D Lateral Cage	3LL1845-2514	FDA UDI	Class II	Active
FOUNDATION System	PLW3211	FDA UDI	Class II	Active
TIGER Spine System	R5506-055	FDA UDI	Class II	Active
TIGER Spine OCT System	35045-22	FDA UDI	Class II	Active
ANODYNE Plate System	20003-046	FDA UDI	Class II	Active
CoreLink 3D Lateral Cage	3LL1855-3014	FDA UDI	Class II	Active
FOUNDATION System	PLW3018	FDA UDI	Class II	Active
FOUNDATION System	841250-14	FDA UDI	Class II	Active
TIGER Spine System	55005-40	FDA UDI	Class II	Active
TIGER Spine System	55001-5	FDA UDI	Class II	Active
TIGER Spine System	77565-35	FDA UDI	Class II	Active
TIGER Spine System	R5504-080	FDA UDI	Class II	Active
TIGER Spine System	55655-35	FDA UDI	Class II	Active
FOUNDATION System	LAT0717	FDA UDI	Class II	Active
TIGER Spine System	60155-60	FDA UDI	Class II	Active
CoreLink Foundation 3D Stand Alone Screw	10455-25	FDA UDI	Class II	Active
TIGER Spine System	R55080-110	FDA UDI	Class II	Active
TIGER Spine System	55080-110	FDA UDI	Class II	Active
FOUNDATION System	840845-11	FDA UDI	Class II	Active
TIGER Spine OCT System	R3500-095	FDA UDI	Class II	Active
TIGER Spine System	77865-60	FDA UDI	Class II	Active
CoreLink 3D Lateral Cage	3LL1845-3016	FDA UDI	Class II	Active
FOUNDATION System	870050-14	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS3045-0815	FDA UDI	Class II	Active
FOUNDATION System	CP0008	FDA UDI	Class II	Active
FOUNDATION System	870045-12	FDA UDI	Class II	Active
FOUNDATION System	CL0412	FDA UDI	Class II	Active
TIGER Spine OCT System	35040-46	FDA UDI	Class II	Active
TIGER Spine OCT System	35735-20	FDA UDI	Class II	Active
TIGER Spine System	55495-55	FDA UDI	Class II	Active
TIGER Spine System	55295-110	FDA UDI	Class II	Active
FOUNDATION System	LCL0409	FDA UDI	Class II	Active
TIGER Spine System	55635-45	FDA UDI	Class II	Active
FOUNDATION System	XA0717	FDA UDI	Class II	Active
TIGER Spine System	55685-100	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.