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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 38 of 72

Device	Model / Reference	Registries	Class	Status
FOUNDATION System	CL0712	FDA UDI	Class II	Active
FOUNDATION System	SAT1315	FDA UDI	Class II	Active
FOUNDATION System	PLW3209	FDA UDI	Class II	Active
FOUNDATION System	XAT1313	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS2535-0815	FDA UDI	Class II	Active
FOUNDATION System	SAT0710	FDA UDI	Class II	Active
TIGER Spine System	55300-80	FDA UDI	Class II	Active
TIGER Spine System	60330-50	FDA UDI	Class II	Active
ANODYNE Plate System	21446-20	FDA UDI	Class II	Active
ANODYNE Plate System	21446-18	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS2535-2019	FDA UDI	Class II	Active
FOUNDATION System	XA0711	FDA UDI	Class II	Active
FOUNDATION System	LCP0012	FDA UDI	Class II	Active
FOUNDATION System	830860-10	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS3045-1517	FDA UDI	Class II	Active
TIGER Spine System	77355-50	FDA UDI	Class II	Active
FOUNDATION System	860035-11	FDA UDI	Class II	Active
TIGER Spine System	77665-30	FDA UDI	Class II	Active
TIGER Spine System	77375-25	FDA UDI	Class II	Active
TIGER Spine System	55575-45	FDA UDI	Class II	Active
FOUNDATION System	830050-12	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS3040-0810	FDA UDI	Class II	Active
TIGER Spine OCT System	R3531-150	FDA UDI	Class II	Active
TIGER Spine System	61210-01	FDA UDI	Class II	Active
TIGER Spine System	R5516-100	FDA UDI	Class II	Active
TIGER Spine System	55275-45	FDA UDI	Class II	Active
TIGER Spine System	55845-45	FDA UDI	Class II	Active
CoreLink Foundation 3D Lateral Cage	3LL2255-3020	FDA UDI	Class II	Active
TIGER Spine OCT System	35735-10	FDA UDI	Class II	Active
FOUNDATION System	870045-08	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS2535-3016	FDA UDI	Class II	Active
TIGER Spine System	77685-70	FDA UDI	Class II	Active
CoreLink 3D Lateral Cage	3LL1860-3018	FDA UDI	Class II	Active
TIGER Spine System	61175-80	FDA UDI	Class II	Active
FOUNDATION System	870030-11	FDA UDI	Class II	Active
TIGER Spine System	51075-50	FDA UDI	Class II	Active
FOUNDATION System	841250-12	FDA UDI	Class II	Active
TIGER Spine System	55505-120	FDA UDI	Class II	Active
FOUNDATION System	840060-11	FDA UDI	Class II	Active
TIGER Spine System	55555-60	FDA UDI	Class II	Active
TIGER Spine OCT System	35301-16	FDA UDI	Class II	Active
FOUNDATION System	830855-16	FDA UDI	Class II	Active
FOUNDATION System	830045-12	FDA UDI	Class II	Active
TIGER Spine System	55865-30	FDA UDI	Class II	Active
ANODYNE Plate System	20003-060	FDA UDI	Class II	Active
TIGER Spine System	77505-60	FDA UDI	Class II	Active
FOUNDATION System	XAT0716	FDA UDI	Class II	Active
TIGER Spine OCT System	35740-18	FDA UDI	Class II	Active
TIGER Spine System	55465-50	FDA UDI	Class II	Active
TIGER Spine System	R5512-060	FDA UDI	Class II	Active

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Authorised Representatives

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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.