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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 72 of 72

Device	Model / Reference	Registries	Class	Status
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS2735-2518	FDA UDI	Class II	Active
CoreLink Foundation 3D ALIF Stand-Alone Cage	3AS2535-2521	FDA UDI	Class II	Active
CoreLink Foundation 3D Stand Alone Screw	10465-25	FDA UDI	Class II	Active
Anodyne Anterior Cervical Plate System	K121514	FDA 510(k)	Class II	Active
CoreLink Navigation Instruments	K214059	FDA 510(k)	Class II	Active
Lateral Plate System	K190016	FDA 510(k)	Class II	Active
Foundation 3D Interbody	K162496	FDA 510(k)	Class II	Active
CoreLink® M3™ Stand-Alone Anterior Lumbar System	K180814	FDA 510(k)	Class II	Active
Foundation Cage	K073440	FDA 510(k)	Class II	Active
Terrace™ Anterior Cervical Plate System	K163104	FDA 510(k)	Class II	Active
Tiger® Occipital-Cervical-Thoracic Spinal Fixation System	K200863	FDA 510(k)	Class II	Active
F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System	K231743	FDA 510(k)	Class II	Active
Zou Anterior Lumbar Plate System	K121791	FDA 510(k)	Class II	Active
Tiger Spine System	K120696	FDA 510(k)	Class II	Active
F3D-C2 Cervical Stand-Alone System	K211417	FDA 510(k)	Class II	Active
Foundation Interbody Devices	K150847	FDA 510(k)	Class II	Active
F3D Cervical Stand-Alone Interbody Fusion System	K200087	FDA 510(k)	Class II	Active
Tiger Spine System	K121728	FDA 510(k)	Class II	Active
CoreLink Navigation Instruments	K232116	FDA 510(k)	Class II	Active
CoreLink Navigation Instruments	K230880	FDA 510(k)	Class II	Active
F3D Interbody System	K230329	FDA 510(k)	Class II	Active
The Entasis Dual-Lead Sacroiliac Implant	K152237	FDA 510(k)	Class II	Active
Tiger Spine System	K133369	FDA 510(k)	Class II	Active
Tiger Spine System	K113058	FDA 510(k)	Class II	Active
CoreLink F3D™ Lateral System	K183239	FDA 510(k)	Class II	Active
CoreLink Navigation Instruments	K212825	FDA 510(k)	Class II	Active
Corelink Navigation Instruments	K182731	FDA 510(k)	Class II	Active
Anodyne Anterior Cervical Plate System	K132994	FDA 510(k)	Class II	Active
Corelink Foundation 3D Anterior Lumbar System	K180556	FDA 510(k)	Class II	Active
Tiger Occipital-Cervical-Thoracic Spinal Fixation System	K132504	FDA 510(k)	Class II	Active
F3D Corpectomy System	K202637	FDA 510(k)	Class II	Active
Tiger Spine System	K110321	FDA 510(k)	Class II	Active
Tiger Spine System	K131250	FDA 510(k)	Class II	Active
Entasis 3D Dual-Lead Sacroiliac Implant System	K223708	FDA 510(k)	Class II	Active
CoreLink Robotic Navigation Instruments	K231494	FDA 510(k)	Class II	Active
CoreLink Midline Fixation System	K210539	FDA 510(k)	Class II	Active
NextGen Pedicle Screw System	K221776	FDA 510(k)	Class II	Active
CoreLink Navigation Instruments	K220973	FDA 510(k)	Class II	Active

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Notified Bodies

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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.