Medical Device Manufacturer · US , Round Rock , TX

Corelink, LLC - FDA 510(k) Cleared Devices

35 submissions · 35 cleared · Since 2008

Recent clearances: F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System, CoreLink Robotic Navigation Instruments, CoreLink Navigation Instruments

35
Total
35
Cleared
0
Denied

FDA 510(k) Regulatory Record - Corelink, LLC Orthopedic ✕

35 devices
1-12 of 35
Cleared Dec 08, 2023
F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and...
K231743 · MAX
Orthopedic · 177d
Cleared Oct 27, 2023
CoreLink Robotic Navigation Instruments
K231494 · OLO
Orthopedic · 157d
Cleared Aug 16, 2023
CoreLink Navigation Instruments
K232116 · OLO
Orthopedic · 30d
Cleared Jun 06, 2023
F3D Interbody System
K230329 · ODP
Orthopedic · 120d
Cleared May 02, 2023
CoreLink Navigation Instruments
K230880 · OLO
Orthopedic · 33d
Cleared Mar 21, 2023
Entasis 3D Dual-Lead Sacroiliac Implant System
K223708 · OUR
Orthopedic · 99d
Cleared Aug 09, 2022
NextGen Pedicle Screw System
K221776 · NKB
Orthopedic · 49d
Cleared Jun 01, 2022
CoreLink Navigation Instruments
K220973 · OLO
Orthopedic · 58d
Cleared Feb 04, 2022
F3D-C2 Cervical Stand-Alone System
K211417 · OVE
Orthopedic · 273d
Cleared Jan 19, 2022
CoreLink Navigation Instruments
K214059 · OLO
Orthopedic · 23d
Cleared Oct 13, 2021
CoreLink Navigation Instruments
K212825 · OLO
Orthopedic · 40d
Cleared Apr 15, 2021
CoreLink Midline Fixation System
K210539 · NKB
Orthopedic · 50d
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