Chrysalis Intelligence · Sponsors · Corelink, LLC

Corelink, LLC

St. Louis, MO, US · 15 510(k) clearances · 1 recalls

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Total clearances

15

2020-04-28 → 2023-12-08

Last 12 months

0

Product codes

8

Most recent

2023-12-08

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	6	2023-10-27
NKB	Thoracolumbosacral Pedicle Screw System	Class II	Orthopedic	2	2022-08-09
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Class II	Orthopedic	2	2022-02-04
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Class II	Orthopedic	1	2023-12-08
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Class II	Orthopedic	1	2023-06-06
OUR	Sacroiliac Joint Fixation	Class II	Orthopedic	1	2023-03-21
MQP	Spinal Vertebral Body Replacement Device	Class II	Orthopedic	1	2020-12-23
NKG	Posterior Cervical Screw System	Class II	Orthopedic	1	2020-04-28

Safety

Recalls (1)

Class I (serious)

0

Risk of injury / death

Total recalls

1

Currently ongoing

0

Most recent

2022-10-20

Date	Severity	Status	Recall #	Product	Code	Reason
2022-10-20	Class II	Terminated	Z-0954-2023	CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208	—	Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.

Filings

All 510(k) clearances (15)

Date	K-number	Device	Code	Class	Specialty
2023-12-08	K231743	F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System	MAX	Class II	Orthopedic
2023-10-27	K231494	CoreLink Robotic Navigation Instruments	OLO	Class II	Neurology
2023-08-16	K232116	CoreLink Navigation Instruments	OLO	Class II	Neurology
2023-06-06	K230329	F3D Interbody System	ODP	Class II	Orthopedic
2023-05-02	K230880	CoreLink Navigation Instruments	OLO	Class II	Neurology
2023-03-21	K223708	Entasis 3D Dual-Lead Sacroiliac Implant System	OUR	Class II	Orthopedic
2022-08-09	K221776	NextGen Pedicle Screw System	NKB	Class II	Orthopedic
2022-06-01	K220973	CoreLink Navigation Instruments	OLO	Class II	Neurology
2022-02-04	K211417	F3D-C2 Cervical Stand-Alone System	OVE	Class II	Orthopedic
2022-01-19	K214059	CoreLink Navigation Instruments	OLO	Class II	Neurology
2021-10-13	K212825	CoreLink Navigation Instruments	OLO	Class II	Neurology
2021-04-15	K210539	CoreLink Midline Fixation System	NKB	Class II	Orthopedic
2020-12-23	K202637	F3D Corpectomy System	MQP	Class II	Orthopedic
2020-06-15	K200087	F3D Cervical Stand-Alone Interbody Fusion System	OVE	Class II	Orthopedic
2020-04-28	K200863	Tiger® Occipital-Cervical-Thoracic Spinal Fixation System	NKG	Class II	Orthopedic