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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 6 of 72

Device	Model / Reference	Registries	Class	Status
FOUNDATION System	880035-16	FDA UDI	Class II	Active
TIGER Spine System	55095-40	FDA UDI	Class II	Active
ZOU Plate System	10000-023	FDA UDI	Class II	Active
TIGER Spine System	55555-30	FDA UDI	Class II	Active
TIGER Spine System	77505-45	FDA UDI	Class II	Active
TIGER Spine System	77695-110	FDA UDI	Class II	Active
FOUNDATION System	SAT0719	FDA UDI	Class II	Active
TIGER Spine System	77585-50	FDA UDI	Class II	Active
TIGER Spine System	TC5500-18	FDA UDI	Class II	Active
FOUNDATION System	MA0711	FDA UDI	Class II	Active
FOUNDATION System	MA1316	FDA UDI	Class II	Active
TIGER Spine System	77865-55	FDA UDI	Class II	Active
TIGER Spine System	61175-25	FDA UDI	Class II	Active
FOUNDATION System	880035-10	FDA UDI	Class II	Active
TIGER Spine System	61155-30	FDA UDI	Class II	Active
TIGER Spine System	61085-50	FDA UDI	Class II	Active
FOUNDATION System	LCP0007	FDA UDI	Class II	Active
TIGER Spine System	61165-50	FDA UDI	Class II	Active
FOUNDATION System	860055-15	FDA UDI	Class II	Active
FOUNDATION System	841255-13	FDA UDI	Class II	Active
TIGER Spine System	60400-00	FDA UDI	Class II	Active
TIGER Spine System	77585-120	FDA UDI	Class II	Active
TIGER Spine System	60065-60	FDA UDI	Class II	Active
TIGER Spine System	60065-45	FDA UDI	Class II	Active
TIGER Spine System	R55090-80	FDA UDI	Class II	Active
FOUNDATION System	870025-15	FDA UDI	Class II	Active
FOUNDATION System	860050-15	FDA UDI	Class II	Active
TIGER Spine System	55045-60	FDA UDI	Class II	Active
TIGER Spine OCT System	35040-38	FDA UDI	Class II	Active
TIGER Spine System	77585-80	FDA UDI	Class II	Active
FOUNDATION System	XA1316	FDA UDI	Class II	Active
TIGER Spine System	R55090-85	FDA UDI	Class II	Active
TIGER Spine System	R55060-90	FDA UDI	Class II	Active
TIGER Spine System	77855-45	FDA UDI	Class II	Active
FOUNDATION System	PMW2610	FDA UDI	Class II	Active
TIGER Spine System	55095-100	FDA UDI	Class II	Active
TIGER Spine System	60185-40	FDA UDI	Class II	Active
TIGER Spine System	77555-55	FDA UDI	Class II	Active
CoreLink 3D Lateral Cage	3LL1855-0012	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS2535-1520	FDA UDI	Class II	Active
FOUNDATION System	LA0709	FDA UDI	Class II	Active
TIGER Spine System	55875-80	FDA UDI	Class II	Active
ANODYNE Plate System	20002-038	FDA UDI	Class II	Active
TIGER Spine System	R55080-130	FDA UDI	Class II	Active
FOUNDATION System	MAT0718	FDA UDI	Class II	Active
TIGER Spine System	61215-00	FDA UDI	Class II	Active
TIGER Spine System	55575-70	FDA UDI	Class II	Active
TIGER Spine System	77505-80	FDA UDI	Class II	Active
TIGER Spine System	55085-120	FDA UDI	Class II	Active
TIGER Spine System	TC5500-20	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.