FDA applicant
Corentec Co., Ltd.
FDA records 33 decisions for Corentec Co., Ltd. (Cheonan, KR) from 2010 to 2025: 33 510(k) clearances. Most are in product codes LPH (Prosthesis, Hip, Semi-Constrained…) and JWH (Prosthesis, Knee, Patellofemorotibial…). Since 2016 its 510(k)s took a median of 85 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 158 predicates, 61 of them its own earlier devices. 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Corentec Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
2in 2024
Class I Class II/III not classified
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