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CORELINK LLC

Last updated May 24, 2026

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 70 of 72

Device	Model / Reference	Registries	Class	Status
TIGER Spine System	60185-55	FDA UDI	Class II	Active
FOUNDATION System	PM2616	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS3040-2021	FDA UDI	Class II	Active
TIGER Spine OCT System	35940-38	FDA UDI	Class II	Active
FOUNDATION System	PL3015	FDA UDI	Class II	Active
TIGER Spine System	55085-35	FDA UDI	Class II	Active
FOUNDATION System	PMW2608	FDA UDI	Class II	Active
ANODYNE Plate System	20340-13	FDA UDI	Class II	Active
TIGER Spine System	61065-45	FDA UDI	Class II	Active
TIGER Spine System	60085-40	FDA UDI	Class II	Active
TIGER Spine System	61085-30	FDA UDI	Class II	Active
CoreLink Foundation 3D Lateral Cage	3LL1860-1210	FDA UDI	Class II	Active
TIGER Spine System	55665-60	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS2535-0820	FDA UDI	Class II	Active
TIGER Spine OCT System	35835-12	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS3045-2015	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS2740-1521	FDA UDI	Class II	Active
TIGER Spine OCT System	35835-16	FDA UDI	Class II	Active
TIGER Spine OCT System	35835-24	FDA UDI	Class II	Active
TIGER Spine OCT System	35745-14	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS2735-1520	FDA UDI	Class II	Active
CoreLink 3D Lateral Cage	3LL1860-0008	FDA UDI	Class II	Active
TIGER Spine OCT System	35845-18	FDA UDI	Class II	Active
CoreLink 3D Lateral Cage	3LL2260-2016	FDA UDI	Class II	Active
TIGER Spine OCT System	R3501-080	FDA UDI	Class II	Active
TIGER Spine OCT System	35035-18	FDA UDI	Class II	Active
TIGER Spine OCT System	35045-14	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Screw	10255-15	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS2540-1520	FDA UDI	Class II	Active
CoreLink Foundation 3D Stand Alone Screw	10455-15	FDA UDI	Class II	Active
TIGER Spine OCT System	R3503-045	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS2535-2516	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS2540-1513	FDA UDI	Class II	Active
CoreLink 3D Lateral Cage	3LL2255-0014	FDA UDI	Class II	Active
TIGER Spine OCT System	R3530-135	FDA UDI	Class II	Active
TIGER Spine OCT System	35745-10	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS2740-3021	FDA UDI	Class II	Active
CoreLink Foundation 3D Lateral Cage	3LL2250-0812	FDA UDI	Class II	Active
CoreLink 3D Lateral Cage	3LL1845-3020	FDA UDI	Class II	Active
TIGER Spine OCT System	R3531-080	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS3040-1519	FDA UDI	Class II	Active
FLXfit 15	AT3208	FDA UDI	Class II	Active
CoreLink 3D Lateral Cage	3LL2235-0808	FDA UDI	Class II	Active
TIGER Spine OCT System	35040-22	FDA UDI	Class II	Active
TIGER Spine OCT System	35940-26	FDA UDI	Class II	Active
TIGER Spine OCT System	35740-22	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS3045-2516	FDA UDI	Class II	Active
TIGER Spine OCT System	R3512-030	FDA UDI	Class II	Active
TIGER Spine OCT System	35735-24	FDA UDI	Class II	Active
TIGER Spine OCT System	R3510-025	FDA UDI	Class II	Active

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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.

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.