Corelink LLC
Country not established
- Devices
- 3,588
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Corelink LLC makes
CoreLink LLC manufactures spinal fixation devices, including non-sterile and sterile bone-screw systems for internal spinal stabilization, non-bioabsorbable spinal plates, and metallic and polymeric interbody fusion cages. Their portfolio also covers orthopaedic bone screws designed for non-sliding applications, as well as lateral screws and 3D lateral cages for spinal support.
All listed devices fall under FDA Class II regulation and are recorded in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
Catalogue
Search and filter all 3,588 devicesShowing 1-50 of 3,588
Company details
- DUNS number
- 064191453
- Phone
- +1(314)863-5401
FDA recalls
FDA recall records list 1 recall initiated by CORELINK LLC, initiated on 2022-10-20. By recorded status: 1 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 1
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2022
- 20 Oct 2022 Z-0954-2023 Class II Terminated Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.
Frequently asked questions
How many devices does CORELINK LLC have in the registry?
The registry currently lists 3588 devices for CORELINK LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list CORELINK LLC's devices?
Among its 50 most recently registered devices, CORELINK LLC has devices listed in FDA GUDID (50 devices).
What risk classes do CORELINK LLC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for CORELINK LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for CORELINK LLC?
FDA recall records list 1 recall initiated by CORELINK LLC, the most recent initiated on 20 Oct 2022. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from CORELINK LLC in the registry?
The most recently registered devices listed for CORELINK LLC include TIGER Spine OCT System 35003-13, TIGER Spine System 77505-35, ANODYNE Plate System 20140-16 and TIGER Spine System 55605-60.