CORENTEC CO., LTD
FDA Regulatory Profile
CORENTEC CO., LTD appears in FDA public data with 3 recalls, 33 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1935-2024, Class II) was initiated on March 29, 2024. Its most recent 510(k) clearance was granted on April 17, 2025.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 33
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1935-2024 | Class II | LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description | March 29, 2024 |
| Z-1934-2024 | Class II | LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Ti | March 29, 2024 |
| Z-1454-2017 | Class II | Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343 | February 27, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250889 | EXULT Knee Replacement System | April 17, 2025 |
| K242401 | EXULT Knee Replacement System | September 12, 2024 |
| K242046 | EXULT Knee Replacement System | August 1, 2024 |
| K223828 | BENCOX Delta Option Heads | March 16, 2023 |
| K223223 | BENCOX Mirabo Z Cup Cortinium | February 27, 2023 |
| K222278 | LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation | August 26, 2022 |
| K210614 | BENCOX Mirabo Z Cup Cortinium | May 24, 2022 |
| K220468 | BENCOX Mirabo Cup System | May 18, 2022 |
| K212034 | LOSPA TKR System | December 9, 2021 |
| K211866 | Bencox THR System | July 14, 2021 |
| K201851 | EXULT Femoral component trial - Left, EXULT Femoral component trial - Right | July 30, 2020 |
| K200395 | LOSPA II Knee System (EXULT Knee Replacement System) | May 7, 2020 |
| K200267 | LOSPA® IS Spinal Fixation System | March 6, 2020 |
| K192507 | LOSPA II Knee System | December 11, 2019 |
| K182221 | Bencox Mirabo Cup Multi Hole | April 1, 2019 |
| K172806 | Bencox Mirabo Cup System | October 17, 2017 |
| K170243 | LOSPA IS TLIF & DLIF Cages | March 31, 2017 |
| K161641 | LOSPA IS ACP System | January 5, 2017 |
| K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System | December 5, 2016 |
| K160157 | LOSPA Modular Knee System | December 1, 2016 |