Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Corentec with 33 510(k) clearances and 3 device recalls. The most recent is a 510(k) clearance dated Apr 17, 2025: EXULT Knee Replacement System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 17, 2025 | EXULT Knee Replacement SystemK250889 · JWH | 510(k) clearances |
| Sep 12, 2024 | EXULT Knee Replacement SystemK242401 · JWH | 510(k) clearances |
| Aug 1, 2024 | EXULT Knee Replacement SystemK242046 · JWH | 510(k) clearances |
| Mar 29, 2024 | LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial InsertClass II · Due to unsupported 10 year expiration date. | Device recalls |
| Mar 29, 2024 | LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: PatellaClass II · Due to unsupported 10 year expiration date. | Device recalls |
| Mar 16, 2023 | BENCOX Delta Option HeadsK223828 · LZO | 510(k) clearances |
| Feb 27, 2023 | BENCOX Mirabo Z Cup CortiniumK223223 · LPH | 510(k) clearances |
| Aug 26, 2022 | LOSPA TKR System Instrumentation, EXULT TKR System InstrumentationK222278 · JWH | 510(k) clearances |
| May 24, 2022 | BENCOX Mirabo Z Cup CortiniumK210614 · LPH | 510(k) clearances |
| May 18, 2022 | BENCOX Mirabo Cup SystemK220468 · LPH | 510(k) clearances |
| Feb 27, 2017 | Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343Class II · Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
