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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 56 of 72

Device	Model / Reference	Registries	Class	Status
TIGER Spine OCT System	35045-46	FDA UDI	Class II	Active
FOUNDATION System	CL0707	FDA UDI	Class II	Active
F3D Sure Size Cervical Cage	3CZLLWW-LLHH	FDA UDI	Class II	Active
TIGER Spine System	60220-01	FDA UDI	Class II	Active
TIGER Spine System	R55070-75	FDA UDI	Class II	Active
FOUNDATION System	880040-14	FDA UDI	Class II	Active
TIGER Spine System	55285-90	FDA UDI	Class II	Active
TIGER Spine System	61075-100	FDA UDI	Class II	Active
FOUNDATION System	860025-15	FDA UDI	Class II	Active
TIGER Spine System	77375-80	FDA UDI	Class II	Active
FOUNDATION System	LAT0715	FDA UDI	Class II	Active
TIGER Spine System	R5505-130	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS3040-1518	FDA UDI	Class II	Active
TIGER Spine System	R5500-055	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS3040-1513	FDA UDI	Class II	Active
TIGER Spine System	77505-45	FDA UDI	Class II	Active
CoreLink 3D Lateral Cage	3LL1860-3014	FDA UDI	Class II	Active
TIGER Spine OCT System	R3530-130	FDA UDI	Class II	Active
FLXfit 15	AT3210	FDA UDI	Class II	Active
TIGER Spine OCT System	R3501-100	FDA UDI	Class II	Active
TIGER Spine OCT System	35935-20	FDA UDI	Class II	Active
TIGER Spine System	55695-110	FDA UDI	Class II	Active
CoreLink 3D Lateral Cage	3LL1840-0008	FDA UDI	Class II	Active
CoreLink 3D Lateral Cage	3LL1860-0010	FDA UDI	Class II	Active
TIGER Spine System	77605-50	FDA UDI	Class II	Active
FOUNDATION System	SA1313	FDA UDI	Class II	Active
TIGER Spine System	55045-45	FDA UDI	Class II	Active
FOUNDATION System	LCL0707	FDA UDI	Class II	Active
FOUNDATION System	840855-11	FDA UDI	Class II	Active
CoreLink LATERAL SCREW	90755-25	FDA UDI	Class II	Unknown
TIGER Spine System	R5504-035	FDA UDI	Class II	Active
TIGER Spine System	55565-50	FDA UDI	Class II	Active
TIGER Spine OCT System	35003-14	FDA UDI	Class II	Active
CoreLink Foundation 3D Stand Alone Screw	10265-20	FDA UDI	Class II	Active
TIGER Spine OCT System	35935-34	FDA UDI	Class II	Active
FOUNDATION System	MA0719	FDA UDI	Class II	Active
TIGER Spine System	55475-100	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS2535-1511	FDA UDI	Class II	Active
CoreLink LATERAL PLATE	900115-20	FDA UDI	Class II	Active
TIGER Spine System	R55070-85	FDA UDI	Class II	Active
TIGER Spine System	77675-25	FDA UDI	Class II	Active
TIGER Spine System	55695-35	FDA UDI	Class II	Active
TIGER Spine OCT System	R3531-085	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS2535-2514	FDA UDI	Class II	Active
FOUNDATION System	XCL0708	FDA UDI	Class II	Active
TIGER Spine System	77375-50	FDA UDI	Class II	Active
TIGER Spine System	55685-35	FDA UDI	Class II	Active
TIGER Spine System	55655-60	FDA UDI	Class II	Active
TIGER Spine System	R5511-065	FDA UDI	Class II	Active
FOUNDATION System	XA1312	FDA UDI	Class II	Active

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Authorised Representatives

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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.