Corentec Co., Ltd
Country not established
Corentec Co., Ltd is a medical device manufacturer, with 9,911 devices listed and 3 FDA recalls as of 13 Nov 2026.
- Devices
- 9,911
- FDA recalls
- 32 ongoing
Registry facts
- Registries
- FDA GUDID 3,000
- FDA 510(k) 1
- Device classes
- FDA Class II 2,677
- FDA Class I 323
- FDA recalls
- Sites and related companies
- Corentec Co., Ltd. South Korea
- Identifiers
- DUNS 688739895
At a glance
Market reach
- United States
- FDA recalls
What Corentec Co., Ltd makes
Corentec Co., Ltd manufactures spinal fixation hardware, including non-bioabsorbable bone screws, polymeric spinal fusion cages, and internal fixation rods for interbody and lateral applications. Their portfolio also includes knee replacement components such as reusable trial prostheses for the tibia and femur, tibial inserts, and modular knee systems for surgical planning. These devices are designed for orthopedic procedures, including spinal stabilization and total knee arthroplasty.
The company’s devices are classified under FDA categories, with most falling into Class I or Class II, and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to regulatory requirements for medical devices in that jurisdiction.
Catalogue
Search and filter all 9,911 devicesShowing 1-50 of 9,911
Company details
- DUNS number
- 688739895
- ra@corentec.com
- Phone
- +82269374902
FDA recalls
Recalls initiated per year
- 2017 1
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 2
- 2025 0
- 2026 0
2024
- 29 Mar 2024 Z-1934-2024 Class II Ongoing Due to unsupported 10 year expiration date.
- 29 Mar 2024 Z-1935-2024 Class II Ongoing Due to unsupported 10 year expiration date.
2017
- 27 Feb 2017 Z-1454-2017 Class II Terminated Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use.
Sites
- Corentec Co., Ltd. KRFEI 3009106092 0 devices
Frequently asked questions
How many devices does Corentec Co., Ltd have in the registry?
The registry currently lists 9911 devices for Corentec Co., Ltd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Corentec Co., Ltd's devices?
Among its 50 most recently registered devices, Corentec Co., Ltd has devices listed in FDA GUDID (50 devices).
What risk classes do Corentec Co., Ltd's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Corentec Co., Ltd's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Corentec Co., Ltd?
FDA recall records list 3 recalls initiated by Corentec Co., Ltd, the most recent initiated on 29 Mar 2024. 2 of them are recorded as ongoing. 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 Corentec Co., Ltd in the registry?
The most recently registered devices listed for Corentec Co., Ltd include LOSPA KA.STA.0013, LOSPA 01.61.121, LOSPA KB.STC.0010 and LOSPA 01.61.170.