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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 49 of 72

Device	Model / Reference	Registries	Class	Status
FOUNDATION System	880040-11	FDA UDI	Class II	Active
TIGER Spine System	60200-00	FDA UDI	Class II	Active
FOUNDATION System	831250-15	FDA UDI	Class II	Active
ANODYNE Plate System	21246-16	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS2740-0813	FDA UDI	Class II	Active
ANODYNE Plate System	20003-054	FDA UDI	Class II	Active
FOUNDATION System	LA1310	FDA UDI	Class II	Active
FOUNDATION System	XA0710	FDA UDI	Class II	Active
TIGER Spine System	77355-60	FDA UDI	Class II	Active
FOUNDATION System	PLW3016	FDA UDI	Class II	Active
FOUNDATION System	870050-10	FDA UDI	Class II	Active
TIGER Spine System	77605-70	FDA UDI	Class II	Active
TIGER Spine System	77375-70	FDA UDI	Class II	Active
TIGER Spine System	55205-100	FDA UDI	Class II	Active
TIGER Spine OCT System	35040-42	FDA UDI	Class II	Active
TIGER Spine System	60215-00	FDA UDI	Class II	Active
TIGER Spine System	55445-55	FDA UDI	Class II	Active
ANODYNE Plate System	20145-17	FDA UDI	Class II	Active
ANODYNE Plate System	20240-14	FDA UDI	Class II	Active
TIGER Spine OCT System	R3502-035	FDA UDI	Class II	Active
TIGER Spine System	55465-60	FDA UDI	Class II	Active
FOUNDATION System	840855-09	FDA UDI	Class II	Active
CoreLink LATERAL SCREW	90760-35	FDA UDI	Class II	Active
TIGER Spine System	77365-40	FDA UDI	Class II	Active
TIGER Spine System	77655-60	FDA UDI	Class II	Active
TIGER Spine System	60325-33	FDA UDI	Class II	Active
FOUNDATION System	870055-16	FDA UDI	Class II	Active
TIGER Spine OCT System	35840-22	FDA UDI	Class II	Active
TIGER Spine System	R5516-200	FDA UDI	Class II	Active
FOUNDATION System	830050-14	FDA UDI	Class II	Active
TIGER Spine System	55585-45	FDA UDI	Class II	Active
TIGER Spine System	60155-45	FDA UDI	Class II	Active
TIGER Spine System	51075-35	FDA UDI	Class II	Active
TIGER Spine OCT System	35140-16	FDA UDI	Class II	Active
TIGER Spine System	55355-50	FDA UDI	Class II	Active
TIGER Spine System	55465-35	FDA UDI	Class II	Active
CoreLink LATERAL PLATE	900315-24	FDA UDI	Class II	Active
TIGER Spine OCT System	R3513-080	FDA UDI	Class II	Active
TIGER Spine OCT System	R3502-080	FDA UDI	Class II	Active
TIGER Spine System	R5512-055	FDA UDI	Class II	Active
TIGER Spine OCT System	R3501-035	FDA UDI	Class II	Active
TIGER Spine System	77875-40	FDA UDI	Class II	Active
FOUNDATION System	831255-10	FDA UDI	Class II	Active
TIGER Spine System	R5510-095	FDA UDI	Class II	Active
TIGER Spine System	61175-25	FDA UDI	Class II	Active
TIGER Spine System	55085-70	FDA UDI	Class II	Active
TIGER Spine System	77655-35	FDA UDI	Class II	Active
FOUNDATION System	840845-14	FDA UDI	Class II	Active
CoreLink Foundation 3D Lateral Cage	3LL2255-1212	FDA UDI	Class II	Active
TIGER Spine System	55845-30	FDA UDI	Class II	Active

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Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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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.